August 2010, Vol 3, No 5 by Green Hill Healthcare Communications, LLC

AUGUST 2010

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VOL 3, NO 5

CONFERENCE NEWS: ASCO

CANCER CENTER PROFILE

Albert Einstein Cancer Center Joins the NCCCP By Dawn Lagrosa

Cancer Care in the Era of Reform By Caroline Helwick

he Health Care and Education Reconciliation Act—ie, “healthcare reform” —essentially “limped to the finish” line on March 30, 2010, after “endless complications” that included the restructuring of one sixth of the US economy, the huge expense of the legislation, and the politicalization of the issues, said Steven K. Stranne, MD, JD, a physician and lawyer with Polsinelli Shughart PC, in their Washington, DC–based office. But this heroic effort is far from the

end of the process, he added. Healthcare reform legislation simply provides an outline for change, leaving many “gaps and ambiguities” yet to be tackled. Federal agencies must fill in many of the important details through rulemaking and guidance documents that will be implemented on a rolling basis. “Healthcare reform continues to be a changing target,” said Stranne, who described how the legislation will affect oncology at the meeting’s “Reimbursement Forum.” Continued on page 4

Left to right: Tiffany Raroha, MSW; William J. Tester, MD, FACP; Lisa Jablon, MD, FACS; and Lawrence J. Solin, MD, FACR, FASTRO.

his past April, Albert Einstein Cancer Center was selected to join the National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP), which in the words of William J. Tester, MD, FACP, medical director of Einstein’s Cancer Center, offers “an opportunity to bring more resources to our patients.” Using $40 million in funding from the American Recovery and Reinvestment Act, the NCCCP has expanded its number of community-based sites from 16 to 30. Einstein was one of 14 medical centers chosen to expand the program. NCCCP is designed to create new research opportunities across the cancer care continuum from screening and treatment to follow-up and survivorship care. NCCCP cancer centers are also tasked to reduce healthcare disparities and improve the quality of care at community hospitals.

Reducing disparities With its mission of delivering high-quality care, Albert Einstein Cancer Center (Einstein) has already been working to overcome those barriers that contribute to healthcare disparities. Located in north Philadelphia, Einstein serves a diverse population that includes large African-American, Hispanic, and Asian subpopulations. In this urban setting, Einstein delivers care to patients from multiple socioeconom-

FINANCING

Equipment Financing: Weighing the Options An interview with Peter S. Myhre By Dawn Lagrosa

edical equipment, especially oncology and radiation equipment, is an integral element in providing patients with high-quality care. However with the high cost of such equipment, the decision on how to finance these expenditures can be complex. In an interview with Journal of Multidisciplinary Cancer Care, Peter S. Myhre, senior vice president, Healthcare Financial Services Division, Wells Fargo Equipment Finance, explains the various financing options available, detailing the

advantages and disadvantages of the different types of products. In addition, he offers advice on what to expect when applying for credit as well as what to look for in a lender. What are the advantages and disadvantages of lease and loan options for equipment financing? There are advantages and disadvantages to both a lease and a loan. The decision whether to lease or obtain a loan needs to be made in light of each health-

Continued on page 28

Inside Conference News Improving health literacy and numeracy

Psychosocial Issues A team approach to psychosocial care

COMPLIMENTARY Benchmarking Benchmarking performance in CME CREDIT a physician-owned practice Multidisciplinary approach to page 22 metastatic nonseminomatous germ-cell testis tumors page 16 Oncology Drug Codes Medications used for the treatment of colorectal cancer

page 20

page 24

Clinical Pathways Selecting the appropriate pathways program page 10

page 7

Novel agent has striking activity in lung cancer subset page 8

Continued on page 12

Fostering a Dialogue to Improve Patient Care & Outcomes

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Editorial Board EDITOR-IN-CHIEF

Mark J. Krasna, MD St. Joseph Cancer Institute Towson, MD Surgical Oncology

Scott E. Eggener, MD University of Chicago Chicago, IL Surgical Oncology

Arun Kumar, MD

Greg Pilat, MBA

VA Medical Center Huntington, WV Medical Oncology

Advocate Health Care Oak Brook, IL Oncology Administration

Shaji K. Kumar, MD

Cristi Radford, MS, CGC

Mayo Clinic Rochester, MN Hematology-Oncology

Sarasota Memorial Hospital Sarasota, FL Genetic Counseling

Ritu Salani, MD

John F. Aforismo, BSc Pharm, RPh, FASCP

Beth Faiman, RN, MSN, APRN, BC, AOCN

RJ Health Systems International Wethersfield, CT Oncology Pharmacy

Cleveland Clinic Taussig Cancer Institute Mayfield Heights, OH Oncology Nursing

Elizabeth Bilotti, RN, MSN, APNc

Mehra Golshan, MD

Terry Macarol, RT(R)(M)(QM)

John Theuer Cancer Center Hackensack University Medical Center Hackensack, NJ Oncology Nursing

Dana-Farber Cancer Institute Boston, MA Surgical Oncology

Advocate Health Care Oak Brook, IL Radiological Technology

Ohio State University Medical Center Columbus, OH Medical Oncology

Nicole A. Bradshaw, MS, CIC

Patrick A. Grusenmeyer, ScD, FACHE

Patrick Medina, PharmD, BCOP

Andrew Salner, MD

Mountain States Tumor Institute Nampa, ID Oncology Administration

Christiana Care Health System Newark, DE Oncology Administration

Oklahoma University College of Pharmacy Oklahoma City, OK Oncology Pharmacy

Hartford Radiation Oncologists Association Hartford, CT Radiation Oncology

Anna M. Butturini, MD

Marilyn Haas, PhD, CNS, ANP-BC

Patricia Molinelli, MS, RN, APN-C, AOCNS

Timothy G. Tyler, PharmD, FCSHP

CarePartners Asheville, NC Oncology Nursing

Somerset Medical Center Somerville, NJ Oncology Nursing

Comprehensive Cancer Center Desert Regional Medical Center Palm Springs, CA Oncology Pharmacy

Dawn Holcombe, MBA, FACMPE, ACHE

Judy A. Olson, RT(R), RDMS

Gary C. Yee, PharmD, FCCP, BCOP

Children’s Hospital Los Angeles Los Angeles, CA Medical Oncology

Minsig Choi, MD G. V. Montgomery VA Medical Center Jackson, MS Medical Oncology

Steven L. D’Amato, RPh, BCOP Maine Center for Cancer Medicine Scarborough, ME Oncology Pharmacy

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DGH Consulting South Windsor, CT Oncology Administration

Patricia Hughes, RN, MSN, BSN, OCN Piedmont Healthcare Atlanta, GA Oncology Nursing

St. Luke’s Mountain States Tumor Institute Boise, ID Oncology Administration

University of Nebraska Medical Center Omaha, NE Oncology Pharmacy

Nicholas Petrelli, MD

Burt Zweigenhaft, BS

Helen F. Graham Cancer Center Christiana Care Health System Newark, DE Surgical Oncology

BioPharma Partners LLC New York, NY Managed Care

august 2010 I VOL 3, NO 5

INTRODUCTION

PUBLISHING STAFF Publisher Philip Pawelko phil@greenhillhc.com Editorial Director Karen Rosenberg karen@greenhillhc.com Managing Editor Dawn Lagrosa dawn@greenhillhc.com Directors, Client Services John W. Hennessy john@greenhillhc.com Cristopher Pires cris@greenhillhc.com Production Manager Marie RS Borrelli Business Manager Blanche Marchitto blanche@greenhillhc.com Executive Administrator Andrea Boylston Circulation Department circulation@greenhillhc.com Editorial Contact: Telephone: 732-992-1891 Fax: 732-656-7938

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am excited to talk to you about two new opportunities for our patients. The National Cancer Institute (NCI) Community Cancer Centers Program (NCCCP) has expanded research benefitting patients at its 16 member hospitals and added 14 new hospitals to its current network, for a total of 30 sites in Mark J. Krasna, MD 22 states. As one of the program’s ST. JOSEPH CANCER principal investigators (at St. INSTITUTE Joseph Cancer Institute, TowEditor-in-Chief son, Maryland), I welcome the new members to our group. This opportunity to collaborate and share knowledge with cancer professionals from diverse regions of our country fills me with anticipation as to what I will learn from them. As this month’s profile demonstrates, these new member centers are equally excited, already planning ways to enhance services for their patients. Research aspects of the program are also moving forward. At the close of the 3-year pilot period, NCCCP centers continue to build the infrastructure for increasing

minority accrual to NCI clinical trials and collect prospective data to determine the impact of multidisciplinary clinics on patient outcomes, including time to treatment, patient satisfaction, and survival. The NCI will be releasing our findings at the end of the year. Of course, much is happening in the world of cancer care. Many of you likely attended the annual meeting of the American Society of Clinical Oncology (ASCO), at which you had to choose presentations to attend, missing others given at the same time. We hope our coverage of some key presentations help fill that gap. The ASCO meeting’s reimbursement forum highlighted challenges and trends in how cancer care will be paid for in the future: integrated care; bundling payment for episodes of care; risk-sharing among providers; improved coordination among providers; formation of networks of providers; and the development of accountable care organizations. One such payment design is clinical pathways, but what pathways programs really are is an area of confusion for many. In this issue, Dawn Holcombe offers advice on how to choose a model that works for you and your payer mix. As always, I hope this issue of the Journal of Multidisciplinary Cancer Care benefits your practice and provides ideas on how to move it forward. We look forward to your feedback.

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CONTENTS Journal of Multidisciplinary Cancer Care® (ISSN # 19490321) is published 8 times a year by Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. Telephone: 732.656.7935. Fax: 732.656.7938. Copyright ©2010 by Green Hill Healthcare Communications, LLC. All rights reserved. Journal of Multidisciplinary Cancer Care® is a registered trademark of Green Hill Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America. EDITORIAL CORRESPONDENCE should be addressed to EDITORIAL DIRECTOR, Journal of Multidisciplinary Cancer Care®, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. E-mail: karen@greenhill hc.com YEARLY SUBSCRIPTION RATES: United States and possessions: individuals, $105.00; institutions, $135.00; single issues $17.00. Orders will be billed at individual rate until proof of status is confirmed. Prices are subject to change without notice. Correspondence regarding permission to reprint all or part of any article published in this journal should be addressed to REPRINT PERMISSIONS DEPARTMENT, Green Hill Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205C, Monroe Twp, NJ 08831. The ideas and opinions expressed in Journal of Multidisciplinary Cancer Care® do not necessarily reflect those of the Editorial Board, the Editorial Director, or the Publisher. Publication of an advertisement or other product mentioned in Journal of Multidisciplinary Cancer Care® should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturer with questions about the features or limitations of the products mentioned. Neither the Editorial Board nor the Publisher assumes any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material contained in this periodical. The reader is advised to check the appropriate medical literature and the product information currently provided by the manufacturer of each drug to be administered to verify the dosage, the method and duration of administration, or contraindications. It is the responsibility of the treating physician or other healthcare professional, relying on independent experience and knowledge of the patient, to determine drug dosages and the best treatment for the patient. Every effort has been made to check generic and trade names, and to verify dosages. The ultimate responsibility, however, lies with the prescribing physician. Please convey any errors to the Editorial Director.

august 2010 I VOL 3, NO 5

august 2010 • VOL 3, NO 5

FEATURE ARTICLES 7 Conference News: ASCO Access to investigational agents has been simplified Improving health literacy and numeracy Novel agent has striking activity in lung cancer subset Bevacizumab lengthens progression-free survival in advanced ovarian cancer, effect on overall survival uncertain New monoclonal antibody treatment offers hope for treatment of metastatic melanoma Biologic effective against rare thyroid cancer 10 Clinical Pathways Clinical pathways programs: confusing choices for payers and physicians. Part 1: selecting the appropriate pathways program 16 Continuing Education Multidisciplinary approach to metastatic nonseminomatous germ-cell testis tumors 20 Psychosocial Issues A team approach to psychosocial care 22 Benchmarking Benchmarking performance in a physician-owned practice DEPARTMENTS 24 Oncology Drug Codes Medications used for the treatment of colorectal cancer 26 Recent FDA Approvals

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US ONCOLOGY OFFERS THE BEST OF BOTH WORLDS.

With the United Network of US Oncology, your independent practice has every opportunity to grow and thrive. Because we know each practice is different, we’ve developed a new range of options that let you choose the solutions that best fit your needs. After all, independence doesn’t mean you have to go it alone. To learn more about the United Network of US Oncology, visit usoncology.com/MCC

Conference News ASCO

The following articles are based on presentations at the 46th Annual Meeting of the American Society of Clinical Oncology held in Chicago, Illinois, June 4-8, 2010.

The Era of Reform...continued from cover Comparative effectiveness research expanded Comparative effectiveness research (CER) is part of the national strategy on quality improvement and is a cost-containment strategy as well. Beyond the $1.1 billion in stimulus funding, going forward, the healthcare reform legislation will fund the program by taxing private insurers and Medicare per capita. The legislation also takes CER a step further, by linking the research findings to provider incentives, and it furthers the commitment to CER by creating the new Patient-Centered Outcomes Research Institute (to oversee CER with an independent board of public officials, private sector members, and advisory groups) and by creating a longterm funding mechanism. “While there is support, it is also controversial, and there are opposing views. Some policy makers see the potential

for dramatic cost-savings in the future due to alignment of CER with coverage policies and reimbursement. Others fear rationing based on CER, although the legislation’s language attempts to safeguard against this,” he said. Independent Payment Advisory Board to make the tough decisions A controversial Medicare cost-containment strategy is the creation of an Independent Payment Advisory Board (IPAB). The IPAB is a 15-member board appointed by the President (subject to consent by Congress) designed to insulate tough decisions regarding future payment reductions from the political system. Its initial recommendations are applicable to calendar year 2014. In years when Medicare costs are projected to be unsustainable by the Centers for Medicare & Medicaid Services (CMS) actuary, IPAB propos-

als will take effect unless Congress enacts alternative measures that achieve the same savings as the IPAB proposals. IPAB is prohibited from making proposals that ration care, raise taxes, raise Part B premiums, or change Medicare benefits, eligibility, or lowincome cost-sharing standards. The IPAB is an attempt to control the growth of Medicare but remains controversial. “IPAB proposals could set aside established payment methodologies…which could result in significant cuts for professional services, drugs, and other items,” Stranne noted. What else is coming Alternative payment methodologies will also be part of healthcare reform legislation. The new Innovation Center within CMS has the authority to test and expand the use of innovative approaches to reimbursement. The

Reimbursement Challenges for Oncology Practices SGR a major sticking point Oncology practices are relatively unscathed by direct cuts under healthcare reform; however, they face reimbursement challenges that the legislation does not address, said Steven K. Stranne, MD, JD, a physician and lawyer with Polsinelli Shughart PC, in their Washington, DC–based office, and Joseph Bailes, MD, of Texas Oncology in Austin, who is chair of the American Society of Clinical Oncology’s (ASCO) Government Relations Council. Stranne cited these challenges for oncology practices: • More “underwater drugs,” ie, those reimbursed at rates lower than the purchase cost • The combined effect of inadequate plus unrecognized reimbursement for services provided • Growing administrative burdens placed on practices • Reductions in chemotherapy administration codes planned to be phased-in from 2010 to 2013 in physician office settings • Increasing unwillingness by private payers to absorb underpayments from public programs and unin-

sured patients • Uncertainty of the sustainable growth rate (SGR) situation. Need to fix SGR The lack of a permanent fix for the SGR “is the elephant in the room” when costs are discussed, said Stranne. “Individual members of Congress acknowledge their frustration and embarrassment at not having a permanent fix,” yet as a group they have not found a solution, he said. Bailes referred to the “political problems” associated with the SGR fix. “The congressional interventions over the years have merely delayed the impact of the SGR mechanism rather than reset the base. As a result, the cuts from prior years have continued to accumulate,” he said. “If Congress fails to act now, there will be a 21.3% cut imposed under the SGR mechanism.” ASCO continues to advocate for a permanent legislative fix that removes the accumulation of delayed cuts from the mechanism. To date, Congress has been unable to enact such legislation, and the cost of enacting a permanent fix has risen to approximately $250 billion, according to Bailes. This has

resulted, he said, in the situation facing physicians in 2010: “month-to-month patches enacted by Congress.” In a letter to The New York Times (June 24, 2010), George Sledge, MD, and Allen Lichter, MD, who are, respectively, president and chief executive officer of ASCO, spoke for the oncology community’s frustration when they wrote, “The field of oncology is undergoing serious upheaval now that reductions in Medicare reimbursement rates are in full effect, to the detriment of patient access to care. “Reimbursement for many drugs is less than the actual cost of buying them. Many physicians, unable to cover costs, are sending Medicare patients to other facilities for care, and some are closing their doors altogether…. Physicians need to be reimbursed fully and fairly for the actual cost of providing care to patients. Unless the Medicare reimbursement system is fixed, more practices will be forced to shut down.” On June 24, the House of Representatives voted once again—this time, 417 to 1—to delay the cut in Medicare pay for physicians through November 30, but by December 1, the mandated SGR cut is expected to occur. l

emphasis will be on integrated care; bundling payment for episodes of care; risk-sharing among providers; improved coordination among providers; formation of networks of providers; and the development of accountable care organizations. The American Society of Clinical Oncology (ASCO) is supporting legislation to provide separate reimbursement for treatment planning, advance care consults, and patient education about treatment. This was not part of the initial healthcare reform legislation. This concept is reflected through a demonstration project offered through the Innovation Center. The project aims to provide financial incentives for treatment planning and follow-up care planning in the context of cancer care guidelines and to identify gaps in applicable quality measures. “ASCO will work with CMS on implementing this demonstration project, and will continue to advocate for separate reimbursement of such services,” Stranne said. More money for clinical trials A positive impact on oncology should be felt through mandated reimbursement for the routine costs of clinical trials. (Coverage of experimental products or data collection required solely for the trial is not required.) There are still, however, several outstanding issues: (1) the inadequate percase reimbursement for participation in federally funded trials (currently covering just one third of the cost); (2) the need to secure adequate research funding for the National Institutes of Health (NIH) and National Cancer Institute (NCI) for fiscal year (FY) 2011 and beyond; and (3) the need to address sustainability once the 2-year infusion of research funding from the American Recovery and Reinvestment Act ends. Stranne cautioned that these funding proposals may fall prey to the “difficult mood” on Capitol Hill following the healthcare reform legislation, “though cancer research continues to attract favorable bipartisan support,” he added. What is encouraging is that the President’s budget reflects a 3.2% increase for the NIH in FY 2011, and a corresponding 3.16% increase for the NCI, representing $163 million. “The President’s proposed increase indicates this is a priority to the administration, though funds ultimately appropriated by Congress may differ,” he said. l Conference News continued on page 7

august 2010 I VOL 3, NO 5

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ARE YOU PREPARED?

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Totect® Kit (dexrazoxane) for injection is for intravenous infusion only. Totect is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.

First and only FDA approved treatment for anthracycline extravasation. Supplied as a convenient and accessible complete three day treatment kit for single patient use, which should be proactively stocked on-site and infused as soon as possible and within 6 hours of an anthracycline extravasation. Demonstrates 98% overall efficacy based on two biopsy-confirmed clinical trials1,2 in reducing or avoiding surgical intervention (i.e., surgical debridement, plastic surgery and their related costs), thereby reducing postponement of a patient’s chemotherapy treatments and the avoidance of long-term consequences. Cited in nursing guidelines.3,4 Extravasation management is now a chemotherapy administration safety standard.5

For more information, call 866-478-8274 or visit our website at www.totect.com To order Totect®, contact one of our authorized distributors. ASD Healthcare Cardinal Specialty McKesson/OTN Oncology Supply US Oncology (800) 746-6273 (866) 677-4844 (800) 482-6700 (800) 633-7555 (888) 987-6679 1

Mouridsen HT et al. Treatment of anthracycline extravasation with savene (dexrazoxane). Results from two prospective clinical multicentre studies. Ann Oncol 2007; 18:546-550. 2 Totect® package insert. 3 Polovich M, White JM, Olsen, M (eds.). Chemotherapy and Biotherapy Guidelines and Recommendations for Practice (ed 3). Pittsburgh, PA, Oncology Nursing Society, 2009. 4 Alexander M, Corrigan A, Gorski L, Hankins J, Perucca R. (eds). Infusion Nurses Society Infusion Nursing an Evidence-Based Approach (ed 3). Boston, MA, Infusion Nurses Society, 2009. 5 Jacobsen J., et al. American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards. Oncology Nursing Forum, 2009; 36:651-658. © 2010 Topotarget USA. All rights reserved. TOT0111/7-10 Totect and its logo mark are registered trademarks of Topotarget A/S Image is copyright © Photo Researchers, Inc.

Totect® – Brief prescribing information Please refer to the package insert for full prescribing information. Each Totect carton contains 10 vials of Totect® (dexrazoxane for injection) 500 mg and 10 vials of 50 mL diluent. Indication: Treatment of extravasation resulting from IV anthracycline chemotherapy. Dosage and administration: Totect is a cytotoxic drug. Vial contents must be mixed and diluted before use. Totect should not be mixed or administered with any other drug during the infusion. Administration of Totect should begin as soon as possible and within 6 hours following the anthracycline extravasation. Totect should be given as an intravenous (IV) infusion once daily for 3 consecutive days. The dose of Totect is based on the patient’s body surface area: day one, 1000 mg/m2; day two, 1000 mg/m2; day three, 500 mg/m2. For patients with a body surface area of > 2 m2, a dose of 2000 mg should be given on days 1 and 2, and a dose of 1000 mg should be given on day 3. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the first day. The Totect dose should be reduced 50% for patients with creatinine clearance values of <40 mL/minute. Cooling procedures such as ice packs should be removed from the affected area at least 15 minutes prior to Totect administration. Totect (dexrazoxane for injection) must be reconstituted with diluent supplied in the carton. The patient’s Totect dose is diluted in 0.9% 1000 mL NaCl prior to administration. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.3-5 Direct contact of Totect® with the skin or mucous membranes prior to and following reconstitution should be avoided. If contact occurs, wash immediately and thoroughly with water. Contraindications: None. Warnings and Precautions: Myelosuppression: treatment with Totect is associated with leukopenia, neutropenia, and thrombocytopenia. Hematological monitoring should be performed. Use in Pregnancy: Pregnancy Category D. Totect can cause fetal harm when administered to a pregnant woman. There is no adequate information about the use of Totect in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Adverse reactions: The most common adverse reactions (≥ 16%) are nausea, pyrexia, injection site pain and vomiting.

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Drug Interactions: No drug interactions have been identified. Based on anecdotal reports concurrent use of topical dimethyl sulfoxide (DMSO) at the site of tissue injury may reduce the benefit of Totect. Additionally, nonclinical studies using a mouse model that simulates extravasation of anthracyclines has shown that concomitant treatment with topical DMSO decreases the efficacy of systemic dexrazoxane. Use in Specific Populations: Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of drug to the mother. Renal Impairment: Reduce the Totect dose by 50% In patients with creatinine clearance values <40 mL/min. Pediatric Use: The safety and effectiveness of Totect in pediatric patients have not been established. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Overdosage: There are no data on overdosage. There is no known antidote for dexrazoxane. Carcinogenesis, Mutagenesis, Impairment of Fertility: The carcinogenic potential of dexrazoxane has not been investigated. Nevertheless, a study by the National Cancer Institute has reported that long term dosing with razoxane (the racemic mixture of dexrazoxane, ICRF-187, and its enantiomer ICRF-186) is associated with the development of malignancies in rats and possibly in mice. Dexrazoxane was not mutagenic to bacteria in vitro (Ames assay), but caused significant chromosomal aberrations in mammalian cells in vitro. It also increased the formation of micronucleated polychromatic erythrocytes in mice. Thus, dexrazoxane is mutagenic and clastogenic. The possible adverse effects of Totect on the fertility of humans and experimental animals, male or female, have not been adequately studied. Testicular atrophy was seen with dexrazoxane administration at doses as low as 30 mg/kg weekly for 6 weeks in rats (about 1/5 the human dose on a mg/m2 basis) and as low as 20 mg/kg weekly for 13 weeks in dogs (about half the human dose on a mg/m2 basis).

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Conference News ASCO...continued from page 4

Access to Investigational Agents Has Been Simplified By Caroline Helwick

Photo by © ASCO/Todd Buchanan 2010.

he American Society education website, ASCO of Clinical Oncology University (www.universi (ASCO) and the US ty.asco.org). Food and Drug AdminIf there is scientific eviistration (FDA) jointly andence to suggest that treatnounced the launch of a ment with an unapproved new set of online resources therapy may be beneficial to help physicians fully and the patient has exunderstand the requirehausted all other treatments for expanded access ment options, and is not to investigational drugs. George W. Sledge, Jr, MD eligible for a clinical trial, These resources are now the FDA-regulated expandavailable to all oncologists, free of ed access program gives physicians charge, through ASCO’s physician access to investigational agents.

“Many patients do not meet the often strict criteria for clinical trials. The FDA’s updated expanded access program provides a chance for access to investigational agents, but many physicians and patients have been unclear about its requirements. We were pleased that the FDA offered us the opportunity to help develop comprehensive educational materials to assist oncologists in understanding this process,” said ASCO president George W. Sledge, Jr, MD, of Indiana University. The online modules introduce all the

expanded access programs available; outline the process for requesting expanded access from the physician, FDA, industry, and Institutional Review Board perspectives; and explain physicians’ legal responsibilities for treating patients with an investigational agent outside of a clinical trial. Links to key references and resources as well as helpful resources to use with patients are also available. Included in the modules are a glossary, an Expanded Access request checklist, and helpful templates to ease the development of related paperwork. l

Improving Health Literacy and Numeracy By Dawn Lagrosa

hysicians must lower the demands and complexity of health information to overcome the barriers to health literacy and increase patient understanding and informed decisionmaking, according to a panel of experts chaired by Terry C. Davis, PhD, head of the Behavioral Science Unit of the Feist-Weiller Cancer Center, Louisiana State University Medical Center, Shreveport. Davis pointed out that the need is very real. Citing the National Action Plan to Improve Health Literacy released in May 2010 by the Office of Disease Prevention and Health Promotion, she noted that of English-speaking US adults, only 12% have proficient health literacy skills. In addition, approximately 45% of high school graduates have limited health literacy. Although overall only 21% of US adults are at the lowest (5th grade) reading level, 43% of those on Medicaid and 44% of those on Medicare or with chronic disease read at that low level.1 This means that these individuals, though not completely illiterate, are functionally illiterate, stated Davis. And numeracy is a bigger problem than reading, Davis explained, citing a study of 200 primary care patients that showed that 78% read at ≥9th grade level but only 37% had math skills at that level.2 The impact of low literacy leads to “poorer health choices, riskier health behaviors, less use of preventive services, more delayed diagnosis, more hospitalization with longer stays, poorer health management, and poorer physical and mental health,” noted Davis, who believes that the solution, “is really up to us.” As part of this solution, Davis highlighted the importance of creating

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health information that is accurate, accessible, and actionable. She offered these tips to overcome literacy barriers: • Ensure a user-friendly environment (check-in, forms, signs, personnel) • Avoid medical jargon, use livingroom language • Limit information—write brief takehome information • Repeat and summarize information • Write precise prescriptions and review medication instructions • Use pictures, teaching tools (pamphlets, brown bag meds) • Teach back/show back to confirm understanding. She also recommended the “Tell Me 3” strategy for limiting information3: • Diagnosis—What is my problem? • Treatment—What do I need to do? • Benefit/Context—Why is it important that I do this? Written communication Written communication needs to be easily understood. Focusing on informed consent forms, Cathy A. Coyne, MPH, PhD, Department of Community

ting can greatly impact readability. Modifications that had the highest impact were incorporating more white space, inserting check boxes to promote interactivity with the form, increasing font size (12 point), and “chunking” the information. In addition, they found that a treatment calendar with symbols representing the method of administration “helps patients to understand the protocol and keep in mind how they are going to be getting this medication,” Coyne said. Numerical communication Focusing on the challenge of overcoming poor health numeracy, Angela Fagerlin, PhD, a research assistant professor at the University of Michigan Health System, Ann Arbor, showcased ways to present numerical information that can affect a patient’s treatment decisions. When it comes to frequencies versus percentages, most patients find natural frequencies easier to understand than percentages. For absolute versus relative risk, the same data can lead to different actions. “If you are trying to inform your

Although overall only 21% of US adults are at the lowest (5th grade) reading level, 43% of those on Medicaid and 44% of those on Medicare or with chronic disease read at that low level. Medicine, West Virginia University, Morgantown, discussed how there is more to making a form easier to read than just reducing the number of multisyllabic words and shortening the sentences. Coyne and her colleagues on West Virginia University’s Institutional Review Board have found that format-

patients, you want to use absolute risk presentation…if you are trying to get somebody to do something, relative risk presentation works much better,” Fagerlin explained, careful to note that she would recommend “if you are going to use the relative risk presentation, also use the absolute risk presentation.”

The choice of graphic can also affect patients’ actions. Fagerlin and her colleagues performed a study on graphic information, that compared various types of graphs to determine which best conveyed information to its readers. In a comparison of pie graphs, modified pie graphs (with number ticks included), pictographs (a matrix of 10 x 10 squares), and spark plug pictographs (horizontal colored lines/squares), readers were asked the gist of the information presented and then specific verbatim knowledge, which required them to select numbers directly from the graphs. They found that for gist knowledge, pie graphs worked very well (mean number of correct responses out of two questions, 1.59); however, for verbatim knowledge, few readers were able to pull out the numbers (mean number of correct responses out of four questions, 0.12). Pictographs worked well for both gist knowledge (mean number of correct responses out of two questions, 1.56) and verbatim knowledge (mean number of correct responses out of four questions, 2.17). Incremental risk presentation can be more difficult to explain to patients. Pictographs again can be helpful. Fagerlin recommended presenting baseline risk in one color and highlighting the additional risk in another color. With this method, patients can see not only their total risk, but also how much (or little) is added from their treatment options. l References 1. Evidence Report. Literacy and Health Outcomes. Rockville, MD: Agency for Healthcare Research and Quality; 2004. Publication No. 04-E007-2. 2. Rothman RL, Housam R, Weiss H, et al. Patient understanding of food labels: the role of literacy and numeracy. Am J Prev Med. 2006;31:391-398. 3. Weiss BD. Health Literacy and Patient Safety: Help Patients Understand. 2nd ed. Chicago, IL: AMA Foundation; 2007.

Conference News continued on page 8

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Conference News ASCO...continued from page 7

Novel Agent Has Striking Activity in Lung Cancer Subset By Caroline Helwick

Photo by © ASCO/Todd Buchanan 2010.

n a phase 1 study in adThe majority of patients vanced non–small-cell responded, often within the lung cancer (NSCLC) first 2 weeks of treatment, deemed worthy of a presenand the responses were tation at the plenary sesoften durable,” reported sion, a multinational group Yung-Jue Bang, MD, PhD, of investigators reported of Seoul National improved survival with an University in South Korea. oral investigational agent The data come from an still unfamiliar to most ongoing phase 1 first-inoncologists. human trial of patients with Martin Edelman, MD Crizotinib (PF-1066), ALK-positive NSCLC treatan inhibitor of anaplastic lymphoma ed with crizotinib after their tumors kinase (ALK), targets a fusion protein progressed, often after multiple treatcalled EML4/ALK, which drives tumor ment regimens. Bang presented the growth in 3% to 5% of all NSCLC results from the first 82 patients. patients. In the study presented, crizotinib produced tumor shrinkage in 57% Striking tumor shrinkage observed “Almost all patients had some degree and prolonged remission in 72% of heavily pretreated advanced NSCLC of tumor shrinkage, even though 59% of the patients had received at least two patients with the ALK protein. “Our results were very impressive. previous treatments,” Bang reported.

Objective responses were observed in 57% of the cohort (63% when five unconfirmed partial responses are included), and in 80% who had received no prior treatments for advanced disease. The disease control rate (response or stable disease at 8 weeks) was 87%. At a median follow-up of 6.4 months, median progression-free survival had not yet been reached but is projected to be 72% at 6 months. Seventy-seven percent of patients remain on treatment, including seven patients for more than 1 year, he said. Treatment-related adverse events included nausea (52%), diarrhea (46%), vomiting (43%), and visual disturbance (42%), but virtually all were grade 1 and they tended to resolve over the course of treatment. Based on these preliminary findings,

Bang maintained that “for patients with ALK-positive NSCLC, crizotinib may offer a potential new standard of care.” According to Martin Edelman, MD, of the University of Maryland Greenebaum Cancer Center, Baltimore, the paper’s invited discussant, crizotinib should provide a targeted approach to patients ineligible for inhibitors of the epidermal growth factor receptor (EGFR). A search for EML4/ALK mutations will likely be added to the emerging strategy of testing for mutations in NSCLC, he said. Edelman predicted that crizotinib may eventually change practice but the drug is not yet commercially available. An ongoing phase 3 trial is likely to be positive, “considering the results today,” he said, and the drug should become “a major treatment advance” for this subset. l

Bevacizumab Lengthens Progression-free Survival in Advanced Ovarian Cancer, Effect on Overall Survival Uncertain By Wayne Kuznar

august 2010 I VOL 3, NO 5

Photo by © ASCO/Todd Buchanan 2010.

evacizumab in com• Six cycles of chemotherbination with chemoapy (carboplatin and therapy followed by paclitaxel) followed by maintenance bevacizumab placebo for an additional monotherapy improves pro10 months (arm 1) gression-free survival (PFS) • Six cycles of chemotheraover chemotherapy alone py plus five cycles of bevain the treatment of adcizumab given concurrentvanced ovarian cancers, ly, followed by placebo said Robert A. Burger, MD. maintenance (arm 2) Robert A. Burger, MD Advances in the treat• Six cycles of chemotherament of ovarian cancer py plus five cycles of bevahave been limited during the past cizumab given concurrently, foldecade. Standard therapy for ovarian lowed by maintenance bevacizucancer had been surgery and chemomab alone (arm 3). therapy (carboplatin and paclitaxel). After a median follow-up of 17.4 The new finding means that beva- months, the median PFS for women in cizumab with chemotherapy followed arm 1 was 10.3 months. In women in by continuation of bevacizumab alone arm 3, the median PFS was 14.1 should be considered as one standard months, representing a 28% reduction option in the frontline treatment of in the risk of cancer progression or advanced ovarian cancer, said Burger. death, and a 39% improvement in the He presented results from a study of likelihood of living longer without dis1873 chemotherapy-naïve patients with ease progression. advanced epithelial ovarian, primary All patient subgroups based on age, peritoneal, or fallopian tube cancer who disease stage, and performance status already had surgical debulkment. had improvement in PFS with conPatients were randomized to either: comitant/continuation of bevacizumab

compared with chemotherapy alone or chemotherapy only with concomitant bevacizumab, said Burger, director, Women’s Cancer Center, Fox Chase Cancer Center, Philadelphia. Women in arm 2 did not show an increase in PFS compared with chemotherapy alone.

Bevacizumab with chemotherapy followed by continuation of bevacizumab alone should be considered as one standard option.

No differences emerged in overall survival between the three arms, but the survival data are not yet mature, Burger explained. Adverse events with bevacizumab were similar to previous studies of bevacizumab. Women who received mainte-

nance bevacizumab in addition to their chemotherapy had a higher rate of neutropenia than those treated with chemotherapy alone. Grade 4 or higher neutropenia occurred in 63.3% of those receiving maintenance bevacizumab in addition to chemotherapy, compared with 57.7% of those receiving chemotherapy alone. Grade 3 or higher pain, grade 3 or higher hypertension, and grade 2 or higher gastrointestinal events were also more common with maintenance bevacizumab/chemotherapy compared with chemotherapy alone. Elizabeth A. Eisenhauer, MD, of the National Cancer Institute of Canada Clinical Trials Group, offered that changing the standard of care for advanced ovarian cancer based on the findings of this study would be premature. “A PFS gain of only 3.8 months may not be meaningful to patients,” she said. The mature overall survival data are needed before the full effect of bevacizumab can be placed into a clinical context. l Conference News continued on page 11

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Clinical Pathways

Clinical Pathways Programs: Confusing Choices for Payers and Physicians. Part 1: Selecting the Appropriate Pathways Program By Dawn Holcombe, MBA, FACMPE, ACHE President, DGH Consulting, South Windsor, Connecticut

anaged care payers body of physicians. Periodic seek oncology soreview must be planned to lutions that will ensure the pathways adapt reduce both variation and with the ever-changing cost. Oncology physicians body of clinical knowledge seek stability in their ability that defines oncology, yet to make decisions in the the program must require best interest of their patients sufficient evidence of proof and payer contracts that will before adoption. allow cancer centers and Demand a clear process community offices to con- Dawn Holcombe, MBA, and timeline for the cliniFACMPE, ACHE tinue to provide care. cal review of any pathways Both payers and physior guidelines program. cians are exploring programs, and the Pathway definition. Clinical guidelines word “pathways” is often raised—but are the accepted standard for approprihow those pathways are defined and exe- ate alternatives for treatment of maligcuted makes an enormous difference. nancies, yet the range of guideline alterPayers can choose some program natives for any disease can be compared management options that don’t address with an eight- or ten-lane highway. pathways at all, such as drug manage- Selection of the highway lane for any ment, disease management, and oncol- given patient is up to the physician, and ogy management. Most of these pro- requires little further consideration of grams are imposed from the outside alternatives as long as the chosen treatonto practicing oncologists and typical- ment is part of the list of those described ly result in very short-term savings, cre- as part of the clinical guidelines for that ate tension between physicians and disease. payer, and have a difficult time proving a satisfactory return on investment after the first couple of years. Increasingly, both payers and physi- A true clinical pathway cians are exploring the options offered by is increasingly clarified evidence-based clinical decision-making as the identification of that lead to clinical pathways programs. However, there is great variation among one preferred treatment the current programs, as well as wide for a given state and variation in satisfaction on both sides stage of disease. with current models. Confusion about the choices and ideal construct for a clinical pathways program abound among A true clinical pathway is increasingboth payers and physicians. In order to decide what model of ly clarified as the identification of one clinical pathways would work best for a preferred treatment for a given state and specific payer or physician practice, we stage of disease, which has been selected must first explore the five key differ- via a rigorous clinical review of the ences, and identify the seven key ques- appropriate clinical guideline alternations/issues to consider before selecting tives and selected based first upon clinical efficacy, then toxicity profile, and, a course of action. lastly, assuming comparability across the Distinguishing characteristics of first two criteria, cost of treatment. clinical pathways A clinical pathways program will Clinical source and maintenance. First always allow physician flexibility to and foremost, a viable clinical pathways treat with an off-pathway alternative, program must be firmly grounded in evi- because there is no one preferred treatdence-based clinical information, based ment that will be universally applicable initially upon the clinical parameters to all cancer patients 100% of the time. found in the National Comprehensive The rigorous clinical review of alternaCancer Network’s published clinical tives and definition of clinical pathway guidelines, and must have undergone rig- must be conducted by actively practicorous clinical review by an experienced ing oncologists, with support from

august 2010 I VOL 3, NO 5

oncology pharmacists, and should be completely free of outside influence into the evaluation process. The scope of a pathway should include not only chemotherapy infusables/injectables, but also orals, biotherapies, supportive care drugs, prognostic testing, and ideally also radiation oncology treatments. Clinical trials should always be considered an on-pathway choice. Expect a pathways program to list one preferred treatment tailored to individual states and stages of disease. Anything less is still just a guideline, not a pathway. Point of clinical decision-making. Unless a pathways program is executed at the point of physician medical decision-making (before selection of the patient treatment), it is not part of the decision-making process and becomes an administered treatment-reporting mechanism rather than a clinical pathways program. Similarly, physician medical decision-making is complex for cancer patients, and involves multiple branches and considerations within a given disease to identify the state and stage of the disease, as well as to think through the many complications of each patient’s health and physical status. This is an interactive process and not well-suited to a static, fixed policy or publication. Therefore, the process that supports the pathways program must allow for rapid evidence-based support of the physician’s thoughts and evaluations and produce an end product that integrates with the practice’s technical and care delivery systems. Many of the data elements and decision points (including staging of disease) are not collected in traditional practice and payer claims processing systems. Thus, vendor programs that rely on claims-based reporting, by definition, cannot incorporate the scope of decision-making, tracking, and reporting that is essential to a clinical pathways program. Such programs, thus, default to menus of approved preferred treatments for a general disease, which do not provide physicians or payers the degree of compliance, reporting, or medical decision-making that is expected in a true clinical pathways program. Require a pathways program to

incorporate front-end medical decision-making, not back-end claims reporting. Tracking and monitoring. A true clinical pathways program will allow physicians to select treatment options that are off-pathway where appropriate, but track the reasons and causes for such variation as part of the clinical monitoring feedback loop. Reporting and analysis should be available to the physician on a patient and population basis that includes distribution of treatment by disease stage and state, by physician, and by aggregated population; distribution of new patients by state and stage of disease, drug utilization, and market share by class; and distribution of active versus follow-up patients. One also should expect reporting of patient-capture rate, the on-pathway rate, clinical trial–utilization rates, and reasons for going off-pathway. Very few, if any, electronic health record systems can produce reports at these levels of granularity. Simplistic reporting will not yield results; seek programs that offer a deep granularity of analysis and reporting by state and stage of disease, for all patients, not just a select few. Documented ease of physician use. A point of clinical decision-making tool is only as good as the number of times it is used by physicians in active clinical practice. A clinical pathways program should be able to document and track the rates at which physicians use it for their entire patient population, or for the population of patients for whom the pathways are being applied. Most physicians who embrace the selection of pathways decide to apply the pathways process to all their patients, making ease of use on one pathways platform across all patients essential. For this reason, it is unlikely that a physician or physician practice will embrace more than one clinical pathways platform— making it more likely that payer programs will adapt to accept compliance reporting from whatever platform or platforms have been selected by the physicians practicing in the payer’s geographic market. Allow physicians to select pathways platforms and support platforms that track front-end decision-making, not simply back-end, claims-based reporting.

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Clinical Pathways

Key questions to ask Having defined the distinguishing characteristics of a true clinical pathways program, it is time to identify seven key questions to ask when reviewing possible solutions for payers or physicians: • Am I looking at a true clinical pathways proposal? • What is the source of the clinical content, and what is the process for review and maintenance? • Am I satisfied with the content and depth of compliance rates and reporting for this program? • Does the proposed program offer doc-

umented evidence of physician satisfaction and ease of use at the point of clinical decision-making for the clinical pathways program, and does the compliance reporting track the rates and reasons for both on- and off-pathway use, as well as accrual to clinical trials, at a bare minimum? • Who is responsible for the pathways program, and what are their motivating factors? • Is this program developed directly with the physician and payers, or if there is a third-party vendor involved, what is that party’s role

and financial stake in the program—and is that fully transparent to all parties? • Who stores and controls the data for the program, and what do they do with it? Conclusion When done appropriately, clinical pathways programs will decrease costs and variation in the physician’s office and across the entire cancer spend for payers. Understanding the distinguishing characteristics of pathways programs and asking these seven questions

will help physicians and payers alike separate true clinical pathways programs from programs that are labeled as pathways programs but focus more on preferred menus of treatments—which is a more tightly controlled way of defining guidelines, but which do not deliver the same depth and detail of care and reporting as fully developed pathways programs. l Part 2 of this article will focus on current pathways programs and will appear in the October issue of Journal of Multidisciplinary Cancer Care.

ASCO...continued from page 8

New Monoclonal Antibody Treatment Offers Hope for Treatment of Metastatic Melanoma By Wayne Kuznar

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Photo by © ASCO/Todd Buchanan 2010.

human monoclonal achieved improvements in antibody that blocks overall survival. In the a receptor that downgp100 vaccine plus placebo regulates T-cell responses group, median overall surimproves long-term survival vival was 6.4 months, in patients with previously which is comparable with treated advanced melanoma, results with placebo in preaccording to the results of a vious studies. In the ipiliphase 3 trial. mumab alone and the ipili“This is the first time we mumab plus gp100 vaccine have shown a survival bengroups, median overall surSteven O’Day, MD efit in metastatic melavival was 10.0 months. noma,” said Steven O’Day, MD, lead One-year survival was 44% in investigator of the study, and chief of patients who received combination research and director of the melanoma treatment with ipilimumab plus vacprogram at The Angeles Clinic and cine, and 46% in those treated with Research Institute in Los Angeles. ipilimumab alone, compared with 25% “What is equally impressive is the near in the gp100 vaccine group. Two-year doubling in the 1-year and 2-year land- survival was 22% and 24%, respectivemark overall survival analyses.” ly, compared with 14% in patients in The study was a head-to-head com- the vaccine group. parison of treatments in 676 patients Better disease control was also seen with previously treated, unresectable in both groups treated with ipilimumab. stage III or IV melanoma. There were After 6 months, melanoma progression three treatment arms: monotherapy with was halted in approximately 30% of ipilimumab (n = 137), gp100 peptide patients, compared with only 11% of vaccine alone (n = 136), and the those who received the gp100 vaccine combination of these two agents alone. (n = 403). Serious adverse events were more Ipilimumab is a fully human mono- common in both ipilimumab arms, at clonal antibody that blocks the CTLA- 17.4% and 22.9%, respectively, com4 receptor (CTLA-4 is an antigen pared with 11.4% in the gp100 plus found on T cells that downregulates the placebo arm. T-cell response) and potentiates T-cell Of significance are the side effects activation. gp100 is a vaccine that pro- with ipilimumab related to the immune duces T-cell–specific immune respons- system. These occurred in two thirds of es, and served as the active control arm the ipilimumab arm patients and in for this study. only one third of the gp100 vaccine “By blocking CTLA-4, ipilimumab group. In ipilimumab-treated patients, keeps the T-cell potentiated and hope- T cells began attacking normal tissue at fully leads to antitumor immunity,” sites, the most common being dermatoexplained O’Day. logic, gastrointestinal, endocrine, and Patients in both ipilimumab arms hepatic tissue.

“Ipilimumab represents a new class of T4 potentiators and an important advance for the field of immunooncology,” said O’Day. “Further development of ipilimumab is ongoing, and we are very excited to see that ipilimumab is

being applied to other cancers, particularly non–small-cell lung and prostate cancers. We are very interested in looking at alternative combinations with this drug, as well as in refining its dosage and schedule.” l

Biologic Effective Against Rare Thyroid Cancer By Caroline Helwick

n investigational multitargeted kinase inhibitor slowed progression of medullary thyroid carcinoma, a rare and difficult-totreat thyroid cancer that currently has no established treatment once it has progressed.

This represented a reduction in risk of progression of 54% with vandetanib. Patients treated with vandetanib had a progression rate of 32% compared with 51% treated with placebo (P = .0001). At 24-month follow-up, patients receiving placebo had a median progression-free survival (PFS) of 19.3 months, but PFS had not been reached for patients receiving vandetanib, reported Samuel A. Wells, MD,

head, Thyroid Clinical Research Program, the National Cancer Institute, Bethesda, Maryland. This represented a reduction in risk of progression of 54% with vandetanib, and in an analysis excluding placebo recipients who crossed over to receive this drugs the risk reduction was 73% (P <.0001). “Statistically significant advantages for vandetanib were also evident in the secondary end points of objective response rate, disease control rate, biochemical response, and time to worsening pain,” Wells reported. The drug inhibits tumor angiogenesis and tumor-cell proliferation by targeting multiple receptors. Vandetanib is also being evaluated in non–smallcell lung cancer. This was the largest ever clinical trial for medullary thyroid cancer, including 331 patients with unresectable locally advanced or metastatic disease. l

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Financing Equipment Financing...continued from cover care provider’s financial situto return the equipment at ation. Both a lease and a lease end and upgrade to loan can provide ownership new technology. options, so the healthcare A loan, which is similar provider needs to look at to a capital lease, is designed which product serves its to fulfill the equipment needs the best. needs through borrowing There are two principal without tying up a healthlease products available. One care provider’s existing product is a fair market value ready capital or lines of lease. This lease is what’s credit with the bank. Under Peter S. Myhre most commonly associated a loan, the borrower gains with the word “lease.” The fair market ownership of the equipment at the end value lease provides lower monthly pay- of the contracted term of the financing. ments, and the customer has the option However, a standard bank loan often to return the equipment at the end of the covers only 75% to 80% of equipment lease term or can buy it for the equip- cost, requiring a significant down payment’s then fair market value. The other ment. Loans are always on balance sheet, lease product is referred to as a capital meaning the obligation shows as indebtlease. This lease provides for the auto- edness on the healthcare provider’s matic transfer of equipment ownership books and the interest expense is reflectto the healthcare provider after all the ed in the income statement. required lease payments have been With a properly structured fair marmade. This product is very similar to a ket value lease, only the lease payments loan in that equipment is owned at the end of the lease or loan term under both types of financing. The customer can get the benefits of a loan through capital A differentiator of leases leasing, but there are still differences is that they often include among these three products. options to upgrade, With a fair market value lease or a capital lease, typically 100% of the cost purchase, or return the of equipment is financed. I should also equipment at the end of mention that providers can lease electhe term. In addition, with tronic health record (EHR) systems at a lease, the equipment 100% of cost, depending on the borrower. This financing can even go user typically can avoid beyond the software. In some cases, a down payments, and provider can finance the installation and delivery of the equipment, as well often manufacturers’ as training on the EHR system. A lease required progress typically finances a higher percentage of payments are included. what a healthcare provider is looking to acquire. A differentiator of leases is that they often include options to upgrade, purchase, or return the equipment at are in the income statement as an operthe end of the term. In addition, with a ating expense. Future lease payments lease, the equipment user typically can will generally be reflected in the finanavoid down payments, and often manu- cial statement footnotes. A loan and a facturers’ required progress payments fair market value lease impact the finanare included. In some cases with a loan cial statements very differently. A loan those payments are paid by the borrow- and a capital lease have basically the er and subsequently financed under a same impact on the financial statements. loan. Another distinguishing feature of leasing is that a fair market value lease, What are the tax implications of the if structured properly, will provide the different equipment lease and loan benefits of being off balance sheet. This options? can be very attractive, depending on There are various ways leasing can the healthcare provider’s financial leverage tax benefits to a healthcare statements and how it wants to best dis- provider’s advantage. The financial close the financing. Accounting rules institution has to balance a lot of differmay be changing in the future, in which ent needs of the healthcare provider, case the off-balance-sheet benefits may which for tax benefits may vary dependno longer be available. The timing of ing on the legal entity that is buying the when that change will occur is uncer- equipment. tain. But it is expected to happen. The For example, a nonprofit hospital can additional benefit of the fair market access direct financing on a tax-exempt value lease is that it is a technology basis. The tax benefits provided to the hedge. The lease provides an easier way financial institution for lending to a

august 2010 I VOL 3, NO 5

hospital are passed through to the borrower, which often provides the absolute lowest cost of financing. This lease product typically does not allow for the option to return the equipment at the end of the lease term. In addition, this lease typically is not allowable for a physician group or cancer facility that is a for-profit entity. Another tax implication is that under a loan or a capital lease, the tax benefits of buying the equipment are retained by the borrower or the lessee. Under a properly structured fair market value lease, tax benefits are retained by the lessor, but they are effectively passed through to the customer through lower monthly payments. Depending on the borrower’s tax status, it may be advantageous to do a loan or it may be beneficial to do a fair market value lease. Their tax accountant can provide some answers and can ask the financial institution to provide multiple lease products and compare them. There is not one easy answer, but there are benefits provided with both options. Why lease through a financial institution, such as Wells Fargo, rather than through the manufacturer? A bank and manufacturer typically have very different primary objectives. These objectives may influence the financial products offered and how a customer is treated during the financing term, which can be lengthy. A manufacturer’s finance company, referred to as a captive, is established, first and foremost, to help the manufacturer move its equipment. A bank, however, is typically interested in more than the financing of a particular piece of equipment; it is looking for a relationship that provides the opportunity to offer additional bank products. Captives are generally more transactional in nature; banks are more interested in a longterm relationship. That is somewhat of a generalization, but when looking at the lender’s primary objectives, it is logical that a captive is most interested in moving equipment. Trying to be somewhat objective, all captives are not created equal, and some are relationship oriented. Because of their close relationship with the manufacturer, sometimes discounts and other support is extended to the captive, which can result in attractive financing terms. Someone buying equipment and looking for financing should ask for financing from the manufacturer’s captive as one option to consider. A provider should also get a quote from the bank because of the potential for more advantageous terms. Typically, a bank has better access to capital with a lower cost of funds com-

pared with a captive. Banks have myriad financial products and are, therefore, more interested in understanding the overall business of the customer. The banker’s job is to find solutions for his or her customer. A captive will focus on financing a specific piece of equipment, and can do a very good job on financing for that equipment. A bank, however, will offer financing of that equipment as well as equipment from other vendors, working capital lines, real estate financing, insurance products, investment banking services, and treasury management to name a few. How can a practice determine how much it can afford? A practice must take a hard look at its available cash flow. That will be one of the biggest determiners of what it can afford, and what kind and how much financing will be available. Additional borrowing will impact the healthcare provider’s financial statements—the income statement, the balance sheet, the cash flow statement. Those statements are considerations in how much can be lent or how much a customer should look to borrow. A healthcare provider should look at the available cash flow after payment of the lease or loan to ensure that there will still be adequate excess cash flow to run the business and provide a cushion for unexpected events. Other considerations are the size of the physician practice or cancer treatment facility, how many liabilities the practice already has on its books, and if it wants additional liabilities or prefers to show less debt and more capital. What is involved in qualifying for credit? Is this different for large versus small practices or new versus established practices? If a healthcare provider is financially healthy, it can access needed capital. This would include a larger borrower, a smaller borrower, an established borrower, and even a startup. With a smaller borrower, less information will be required and turnaround time should be quicker. With the financing of smaller transactions, the financial institution can access many online services to get an idea of a borrower’s financial condition. Even for larger financial amounts, an initial assessment can be done rather quickly by a financial institution with significant healthcare expertise. In order to obtain a formal approval, financial statements will be required for the larger financing amounts. If it’s a startup or smaller practice, personal guarantees are typically required—this is a significant difference between a startup or Continued on page 15

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Evolution in

2 OF A SERIES PART

Oncology Practice Management

(

New Jersey Hematology and Oncology Center Partners with OncoMed Bayonne, NJ—As demand for their services grew and it became increasingly clear that their practice was becoming a regional center for patients battling cancer, the medical staff at Colanta Hematology & Oncology Center made the decision to build and open an outpatient infusion center that could adequately and comfortably serve their patients. The result was a state-of-the-art infusion center with 20 recliners in a patientfocused environment that is open to serve patients 7 days a week. The medical staff of 3 physicians and 4 nurses, led by practice administrator Romel Colanta, MD, now delivers a broad array of outpatient oncology services, including chemotherapy, albumin, antiemetic, and iron therapy infusions. Additionally, the infusion center staff provides supportive cancer care services, including therapeutic phlebotomy, antibiotic infusion, and electrolyte replacement. They also provide multidisciplinary infusion services for patients referred to the center by gastroenterologists, neurologists, and infectious disease specialists. With the high volume of oncology drugs required to treat their patient panel, the medical staff at Colanta had to make the decision as to how they would supply their patients with oncology medications. If they followed the traditional practice of hematology and oncology providers, they would “buy and bill” the

medications, meaning they would have the responsibility of sourcing and purchasing the medications, storing them, preparing and sometimes compounding them for patients, managing the inventory on an ongoing basis, and dealing with a bevy of insurance prior authorization and reimbursement procedures and requirements in order to get paid.

est clinical standards, deliver them just in time for treatment day (thereby eliminating waste), handle all the hassles of insurance prior authorization and reimbursement, and free the center from the challenges of safely storing and dispensing the drugs and the huge, capitalintensive “carry costs” that maintaining such an inventory requires.

“The partnership with OncoMed has enabled us to make better use of our capital.” —Romel Colanta, MD Practice Administrator Colanta Hematology & Oncology Center

Although buy and bill traditionally had its benefits, including a substantial margin paid by Medicare and other commercial payers, changes that resulted from the Medicare Modernization Act lowered a margin that sometimes paid physicians 40% over the cost of the drug to just 6%. The Colanta team decided there was a better way. They knew they could outsource the pharmacy function to a pharmacy that was highly specialized in oncology medications. This pharmacy would prepare the drugs under the high-

The outpatient infusion center at Colanta Hematology & Oncology Center comfortably serves patients.

Dr Colanta and his colleagues researched their options and chose OncoMed—The Oncology Pharmacy. OncoMed is an oncology pharmacy, meaning that its sole business is oncology medications. Its specially trained and certified oncology pharmacists work in a technologically advanced pharmacy built exclusively for oncology pharmaceutical prescription processing and dispensing, including a USP <797>-compliant class 5 clean room. To protect the supply chain and ensure a complete and full drug pedigree, all inventories are purchased directly from pharmaceutical manufacturers. The company’s “just-intime treatment-day” service means that oncologists and hematologists in any state in the nation are guaranteed delivery of medications and all therapyspecific administration supplies within 24 hours of placing the order. Given the Colanta Hematology & Oncology Center’s close proximity to one of OncoMed’s regional oncology pharmacy sites, they were eligible to get same day and even emergency stat dose delivery when needed. But what also set OncoMed apart from specialty pharmacies that concentrate on more than one class of pharmaceuticals is the OncoMed care management support team’s ability to work with insurers to get the authorizations that the Colanta Hematology & Oncology Center’s patients need. OncoMed’s team includes

patient care navigators and patient reimbursement specialists who have extensive experience working with insurers, oncology drug manufacturers, and medical foundations. These specialists always know where to go to search for needed funding for patients who are banking on that expertise for their recovery. OncoMed has become a pivotal partner to the Colanta Hematology & Oncology Center by owning the pharmaceutical worry and letting the physicians focus solely on guiding their patients to remission. We sat down with Dr Colanta and asked him about the new center and its partnership with OncoMed. Why did your infusion center choose to partner with OncoMed? The buy-and-bill model that oncologists have always worked under is no longer viable. Physicians can’t make an office run on a 6% margin. Under buy and bill, the average sales price (ASP) + 6% methodology can very quickly go to ASP + 4%, +2%, or -2% if we run into any obstacles in getting reimbursed. And with expensive drugs like chemotherapy, we cannot take that risk. Plus, OncoMed helps patients get funding for medication even after the patient’s insurer has denied coverage. In addition to this new center, you now have 2 additional sites in New Jersey. How has the partnership with OncoMed enabled you to successfully launch and grow the center? When we opened, 90% of what we infused in the clinic was oncolytics. As we have grown, we infuse a far broader array of medications. The backbone of our practice is still chemotherapy, but we have increased our nononcolytic infusions. For patients referred by gastrointestinal practitioners, we infuse infliximab, and for those referred by infectious disease physicians, we provide antibiotic infusions. Some of those drugs are still viable [under buy and bill], but not all. We have been able to devote money that has traditionally gone to purchasing medication and instead expand our services. The partnership with OncoMed has enabled us to make better use of our capital. Continued page Continuedononnext page 15

EVOLUTION IN ONCOLOGY PRACTICE MANAGEMENT™ Continued Continued from from page page 14 22

How does the medication ordering and fulfillment process work with OncoMed? Having an efficient and focused process in place is very important. We have been able to institute a process where we have someone devoted to being our liaison with OncoMed. When a patient comes in and his or her benefits are precertified, we send the person’s case information to OncoMed, and the drugs are sent to us directly, along with all the administration supplies. We get them on a next-day basis, or sooner if needed, and everything is clearly labeled with patient-specific information. That makes a huge difference to us when dealing with OncoMed versus some specialty pharmacies that some insurers have imposed upon us to use, which get the drugs wrong, ship them late, and have no idea of the correct administration supplies. How does the relationship with OncoMed allow you and your team to

focus on what is important? I will give you a “before-and-after” example. Before we worked with OncoMed, 50% or more of our time was spent on managing drug costs and reimbursement. We had 5 people managing pharmacy at the 3 locations; we have been able to reduce that number of employees to 1. Before, we had to continually make sure that we were not underwater on drugs, as reimbursement rates and times fluctuated. OncoMed has made it possible to not devote time and effort on that. Based on your experience, what would you say about OncoMed to hematologists and oncologists considering such a move? It is definitely a relationship that every infusion center or oncologist has to explore. When dealing with narrowing reimbursement margins and delayed reimbursement, ultimately it will be beneficial to switch to OncoMed.

Pharmacists filling orders at the OncoMed facility.

THE LEADERSHIP OF ONCOMED – THE ONCOLOGY PHARMACY

Burt Zweigenhaft CEO, OncoMed

Kevin Askari, RPh President and Chief Clinical Pharmacist OncoMed

Ellen Scharaga, RPh Senior Vice President OncoMed

To learn more about OncoMed or to request a presentation, contact OncoMed at 1-877-662-6633, extension 1298 or marketing@oncomed.net, or go to www.oncomed.net.

Equipment Financing...continued from page 12 smaller practice and a larger practice. When personal guarantees are required, the credit analysis will include retrieval from credit bureaus, and, depending on the size of the transaction, personal financial statements and tax returns may be necessary. For an established cancer treatment facility, personal guarantees may not be required. In those cases, the lender is relying on the demonstrated cash flow of an established business to make the lease payments and will consider the value of the equipment collateral in the event of a default. With radiation treatment equipment, the useful life can be over 10 years, providing the lender very good collateral. A provider can typically access better terms, given the very strong collateral value of top-tier radiation equipment. When financing a startup, the practice doesn’t have a track record. In addition, a startup typically requires financing of soft costs. Therefore, the requirements for a startup versus an established entity are different. A startNO. 2 www.jOmcc.com

up that is installing a radiation treatment device will likely have to build a vault and have significant tenant improvements that can exceed $1 million. These can represent as much as 25% to 35% of the total financing. With these projects, the financial institution will likely need to look at a business plan. There will have to be enough equity in the new business to make sure that, after preopening expenses are paid, working capital available during the startup period will be adequate. Financial institutions will often look at the referral patterns of the physicians involved in the project as support for projected revenues. A solid group of physicians will provide greater comfort for the financial institution. What should a healthcare provider consider before selecting a financial institution? Just as the financial institution will analyze the borrower and assess the project, the healthcare provider should also look closely at the financial institution.

Providers should look for the best financing source, whether it is a bank or a captive or an independent leasing company. The healthcare provider should not think of all financial institutions as being the same. Do your homework. One consideration is whether the financial institution has proven strength and stability so that it can take a financial hit and still be able to honor its obligations to provide financing. Other considerations are how long the institution has been in business and its bond rating. A number of institutions have left the healthcare market, are only doing business with existing customers, or simply do not have capital to lend, making this an important consideration. The financing source should have experience in the healthcare industry and have a team of veteran specialists. These specialists will increase understanding of your business. The institution and the individuals you choose to work with should understand Medicare and thirdparty reimbursement; they should be familiar with regulatory factors and so will

not be surprised by local healthcare market dynamics involving hospitals, physicians, and the payers. All these factors can ultimately impact the approval process as well as the attractiveness of the terms that are approved. Radiation oncologists, developers, joint ventures, and startups should look for financial institutions that are comfortable working with them and have experience in their specialty of oncology and the business of delivering cancer treatment. Finally, a healthcare specialist representing a financial institution should be able to present a variety of financial products including leases and loans and financing that will be off balance sheet. The specialist should be able to explain the tax benefits of each product and provide a number of solutions to meet the specific requirements of the project. The specialist also should be conversant about the manufacturers and the models of equipment used in cancer treatment. In equipment financing, understanding the equipment is an important element to providing the best financing solution. l

august 2010 I VOL 3, NO 5

CONTINUING EDUCATION PROGRAM CME001 • RELEASE DATE: AUGUST 15, 2010 • EXPIRATION DATE: AUGUST 14, 2011 ESTIMATED TIME TO COMPLETE: 1.0 HOUR

Multidisciplinary Approach to Metastatic Nonseminomatous Germ-cell Testis Tumors Philippe E. Spiess, MD, MS; Jose Correa, MD; Surendra Kolla, MD; Wade J. Sexton, MD Genitourinary Oncology Program, H. Lee Moffitt Cancer Center, Tampa, Florida STATEMENT OF NEED

TARGET AUDIENCE

Major improvements have been made in the prognosis of patients with testicular cancer over the past 20 years with overall disease-specific survival rates exceeding 90%, because of the careful integration of improved systemic platinum-based chemotherapy regimens and surgical techniques. This multimodality treatment paradigm consisting of systemic chemotherapy followed by postchemotherapy retroperitoneal lymph node dissection is critical to the management of patients with metastatic nonseminomatous germ-cell tumors (NSGCTs). This requires a commitment by each member of the multidisciplinary team to communicate effectively and acknowledge the individual contributions each can make toward the care and toward the cure of testis cancer patients. This article will help team members recognize thought processes behind the other members’ treatment decisions.

Medical, surgical, and radiation oncologists, and other interested healthcare professionals, especially those caring for cancer patients.

n 2009, testicular cancer is estimated to affect 8400 men and result in 380 deaths in the United States.1 It is the most common malignancy in men aged 20 to 40 years. Hence, by its very nature, testis cancer is a life-altering event in a young subset of patients. Major improvements have been made in the prognosis of patients with testicular cancer over the past 20 years with overall disease-specific survival (DSS) rates exceeding 90%, because of the careful integration of improved systemic platinum-based chemotherapy regimens and surgical techniques.2 Today, this multimodality treatment paradigm consisting of systemic chemotherapy followed by postchemotherapy retroperitoneal lymph node dissection (PCRPLND) is critical to the management of patients with metastatic nonseminomatous germ-cell tumors (NSGCTs). Histology, staging, and prognostic classification of metastatic NSGCTs Testicular cancer can be subdivided into seminomatous tumors (30%-60%)

and NSGCTs (40%-70%). NSGCTs are further categorized into embryonal, yolk sac, choriocarcinoma, and teratoma (mature and immature) histologies, although most NSGCTs comprise a mixture of the aforementioned histologies to include seminomatous elements. Serum tumor markers consisting of serum α-fetoprotein (AFP), β-human chorionic gonadotropin (HCG), and lactic dehydrogenase (LDH) are used in the diagnosis, treatment, and surveillance of testicular cancer. The 1997 American Joint Committee on Cancer Staging System is the most frequently used staging system for testicular cancer: • Stage I—confined to the testis • Stage II—confined to retroperitoneal lymph nodes • Stage IIA—largest retroperitoneal lymph node ≤2 cm • Stage IIB—retroperitoneal lymph nodes between 2 cm and 5 cm • Stage IIC—largest retroperitoneal lymph node >5 cm • Stage III—involve metastatic sites

CONTINUING MEDICAL EDUCATION ACCREDITATION AND DESIGNATION OF CREDIT STATEMENT

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Science Care and Green Hill Healthcare Communications, LLC. Science Care is accredited by the ACCME to provide continuing medical education for physicians. Science Care designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

LEARNING OBJECTIVES

After completing this activity, the reader should be able to: • Recognize the histologic, staging, and prognostic classifications of metastatic nonseminomatous germ-cell tumors (NSGCTs) • Develop management strategies for patients with metastatic NSGCTs based on histologic, staging, and prognostic classifications • Institute a surveillance protocol for patients with NSGCTs following postchemotherapy retroperitoneal lymph node dissection

ers (AFP >10,000 ng/mL, HCG other than retroperitoneal lymph >50,000 IU/L, and LDH >10 x nodes. upper limit of normal). Patients with NSGCTs can be categorized into Systemic chemotherapy three prognostic groups for metastatic NSGCTs according to the 1997 Historically, actinomycin International Germ Cell D was one of the first sysConsensus Classification temic agents used in the (IGCCC) guidelines3: • Good—testis/retroperimanagement of NSGCTs, toneal primary, no nondemonstrating response pulmonary visceral metrates of about 50% and astases, and favorable complete response rates tumor markers (AFP Philippe E. Spiess, MD, MS between 15% and 20%.4 <1000 ng/mL, HCG <5000 IU/L, Subsequently, single-agent vinblastine and LDH <1.5 x upper limit of nor- and bleomycin were proposed and achieved similar response rates to the mal) • Intermediate—testis/retroperitoneal actinomycin D regimen.5 Thereafter, it primary, no nonpulmonary visceral was noted that metastatic NSGCTs metastases, and intermediate-risk exhibited significantly better response tumor markers (AFP 1000 ng/mL to rates to multiagent platinum-based 10,000 ng/mL, HCG 5000 IU/L to chemotherapy, and the traditional 50,000 IU/L, and LDH 1.5 x to 10 x bleomycin, etoposide, and cisplatin (BEP) regimen was adopted as a firstupper limit of normal) • Poor—mediastinal primary germ-cell line approach for metastatic disease.6 tumor, or nonpulmonary visceral One of the major concerns with the metastases, or high-risk tumor mark- BEP regimen, however, is bleomycinFINANCIAL DISCLOSURES

As a provider accredited by the ACCME, Science Care must ensure balance, independence, objectivity, and scientific rigor in all its activities. All course directors, faculty, planners, and any other individual in a position to control the content of this educational activity are required to disclose to the audience any relevant financial relationships with any commercial interest. Science Care must determine if the faculty's relationships may influence the educational content with regard to exposition or conclusion and resolve any conflicts of interest prior to the commencement of the educational activity. Disclosures are as follows: • Jose Correa, MD, has nothing to disclose. • Karen Rosenberg has nothing to disclose. • Surendra Kolla, MD, has nothing to disclose. • Wade J. Sexton, MD, has nothing to disclose. • Dawn Lagrosa has nothing to disclose. • Philippe E. Spiess, MD, MS, has nothing to disclose.

METHOD OF PARTICIPATION

1. Read the article in its entirety 2. Go to www.JOMCC.com 3. Select "Continuing Education" 4. Click on this article's title from the list shown 5. Select "Click here to complete the posttest and obtain a CME certificate online" 6. Complete and submit the CME posttest and CME Activity Evaluation 7. Print you Certificate of Completion

The staff of Science Care have nothing to disclose. DISCLAIMER

The opinions and recommendations expressed by faculty, authors, and other experts whose input is included in this program are their own and do not necessarily represent the viewpoint of Science Care or Green Hill Healthcare Communications, LLC. Copyright © 2010 Science Care. All rights reserved.

This activity is provided free of charge to participants.

august 2010 I VOL 3, NO 5

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www.JOMCC.com induced pulmonary toxicity. Therefore, with disease progression after secondthe doublet regimen of etoposide and line VIP-based chemotherapy, high-dose cisplatin (EP) has been proposed. chemotherapy and autologous boneAlthough still highly debatable, some marrow transplantation are typically oncologists believe that for good-risk recommended.11 IGCCC patients, four cycles of EP may have efficacy similar to three cycles of Indications for PC-RPLND There are clear indications for PCBEP. Others argue that three cycles of BEP has improved treatment-specific RPLND in patients with NSGCTs. The outcomes, albeit at the expense of most common indication is the presence potentially higher pulmonary toxicity.7,8 of a radiographic residual mass in the Currently, both regimens are consider- patient who has received systemic chemoed acceptable for good-risk patients therapy for metastatic disease and who has according to the National normal tumor markers. PathComprehensive Cancer ologic findings in the resectNetwork guidelines and are ed surgical specimen from the most frequently used patients undergoing PCfirst-line systemic therapy RPLND following induction regimens for metastatic chemotherapy (typically BEP NSGCTs.9 For patients x 3 or EP x 4 for good-risk exhibiting marker elevation patients, BEP x 4 for intermeor disease progression after diate- and poor-risk patients) first-line chemotherapy, include fibrosis in 40%, teradditional systemic chemoatoma in 40%, and viable Jose Correa, MD therapy is often recomgerm-cell tumor in 20%.12 As mended, typically consisting of vinblas- such, 60% of patients will derive a benefit tine, ifosfamide, and cisplatin (VIP), as from surgery by the resection of viable this regimen has been shown to be an cancer or teratoma. The risk of having efficacious second-line salvage therapy viable cancer in the surgical specimen with acceptable toxicity.10 For patients increases to 50% or more in patients

undergoing PC-RPLND following salvage presence of viable germ-cell elements chemotherapy.13 other than teratoma. The “desperation Another indication for PC-RPLND PC-RPLND” is an attempt to surgically is in the patient with tumor growth dur- resect all sites of disease. Although hising or after systemic chemotherapy, torically associated with a poor prognodespite normalization of serum tumor sis, more recent experience details optimarkers. This condition is characteris- mistic outcomes in 48 patients undergoing tic of growing teratoma syndrome “desperation PC-RPLND,” with 79% of (GTS).14 In a recent surgical series, the patients exhibiting no evidence of disexcellent outcomes of patients with ease at a median follow-up of 46 GTS managed by PC-RPLND were months.16 A controversial indication for a PCconfirmed.15 It is important to follow the serum tumor markers and the radio- RPLND involves patients with metastalogic response of metastatic germ-cell tic NSGCTs with complete radiographtumors to chemotherapy, because GTS ic resolution of metastatic sites and is chemorefractory and normalization of serum should be managed by PCtumor markers. The risk of RPLND within several relapse in this subset of weeks of the diagnosis. A patients is approximately delay in surgery could 5% without PC-RPLND, increase the complexity which most surgical oncoloand the morbidity of the gists would accept as suffisurgical resection. ciently low to negate the Finally, a “desperation necessity of PC-RPLND in PC-RPLND” is indicated in this patient cohort.17 A recent study corroborates some patients with metaSurendra Kolla, MD the favorable natural history static NSGCTs who despite treatment with maximal courses of of metastatic tumors in patients who chemotherapy, have persistently elevat- attain a complete response (radiographed serum tumor markers, indicating the ic and serologic) and who undergo sur-

Table. Recommended Surveillance Protocol in Testicular Cancer Patients Following PC-RPLND 3

Clinical stage IIA History Physical examinationa Serum tumor markersb Chest x-ray Abdominal/pelvic CT imaging

x x x x x

Yearly for 5 years

x x x x x

Clinical stage IIB History Physical examinationa Serum tumor markersb Chest x-ray Abdominal/pelvic CT imaging

x x x x x

Clinical stage IIC History Physical examinationa Serum tumor markersb Chest x-ray Abdominal/pelvic CT imaging

x x x x x

Clinical stage III History Physical examinationa Serum tumor markersb Chest x-ray Abdominal/pelvic CT imaging

x x x x

x x x x x

x x x x

x x x x x

x x x x

x x x x x

x x x x

x x x x x

x x x x

x x x x x

x x x x

Physical examination includes a head and neck examination and brief neurologic evaluation. Serum tumor markers include α-fetoprotein (AFP), β-human chorionic gonadotropin (HCG), and lactic dehydrogenase (LDH). CT indicates computed tomography; PC-RPLND, postchemotherapy retroperitoneal lymph node dissection. Reprinted with permission from Spiess PE, Brown GA, Liu P, et al. Recurrence patterns and proposed surveillance in patients following post-chemotherapy retroperitoneal lymph node dissection. J Urol. 2007;177:131-138. Copyright © 2007. Elsevier/American Urological Association.

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august 2010 I VOL 3, NO 5

CONTINUING EDUCATION veillance only following chemotherapy.18 Nevertheless, some centers still promote PC-RPLND in this clinical context.19

pathologic features. Fizazi and colleagues reviewed the outcomes of 238 patients with viable residual NSGCTs following first-line chemotherapy.23 The overall 5-year PFS was 64% and, on Treatment-related outcomes multivariate analysis, the significant PC-RPLND is an essential diagnostic predictors included incomplete surgical and therapeutic intervention in patients resection, viable malignant cells >10%, with metastatic NSGCT. Technical and poor or intermediate IGCCC caterefinements and a better understanding gories. Patients not having any of these of retroperitoneal anatomy and physi- adverse features had a 5-year PFS of ology have resulted in significant 90%, compared with 41% in patients improvements in the disease-specific with two or more adverse features.23 On outcomes as well as minimizing treat- the contrary, Spiess and colleagues evalment-related morbidity. The prognosis uated the treatment-related outcomes of patients undergoing PC-RPLND is of patients with no viable tumor in the most strongly correlated with the PC-RPLND specimen.24 Of 195 papathologic findings at the time of sur- tients with fibrosis and/or teratoma at gery. Patients with fibrosis and/or ter- the time of PC-RPLND, 18% (35) of paatoma have a 10% to 18% risk of tients developed subsequent recurrences relapse, whereas patients with viable and 9% (18) died of disease at a median germ-cell tumor elements have up to a follow-up of 45 months. On multivari70% risk of relapse despite the adminis- ate analysis, the only predictors of RFS tration of two additional cycles of adju- in these patients was advanced clinical stage (IIC-III), and the predictors of vant chemotherapy.20 Factors predictive of DSS have been DSS included an elevated serum HCG determined from retrospective reviews before PC-RPLND, pathologic diameand multivariate analyses of patients ter of the retroperitoneal mass (>2.5 undergoing PC-RPLND. These factors cm), and postoperative tumor recurinclude systemic symptoms at presenta- rence. Therefore, although patients tion, elevated pre-RPLND serum AFP with fibrosis or teratoma only in the (>9 ng/mL) or HCG (>4100 IU/L), PC-RPLND specimen have a lower risk postoperative complications, and can- of disease recurrence compared with cer recurrence after PC-RPLND.19 patients with viable germ-cell elements, Recurrence-free survival (RFS) is both subsets of patients require careful impacted by advanced clinical stage postoperative surveillance to detect and (IIC-III) and the presence of viable treat disease recurrences.25 As previously described, a subset of tumor in the PC-RPLND specimen.21 Furthermore, the clinical outcomes of patients have elevated serum tumor patients harboring viable germ-cell markers despite receiving the maximal tumor elements at the time amount of preoperative of PC-RPLND were evaluchemotherapy and may be ated, and an attempt was offered a “desperation PCmade to determine whether RPLND” in an attempt to the presence of viable tumor remove all sites of visible in the surgical specimen disease. Beck and colleagues could be predicted.22 The updated their single-center incidence of viable tumor at experience with the “desthe time of PC-RPLND in peration PC-RPLND” group the good, intermediate, and of patients and found viable poor IGCCC categories germ-cell tumor elements Wade J. Sexton, MD were similar (17.8%, 15.6%, in more than 50% of paand 15.3%, respectively); however, the tients.26 After a median follow-up of 6 IGCCC prognostic categories predicted years, 54% of patients remained alive. DSS and RFS consistent with the earli- On multivariate analysis, several predicer findings of the International Germ tors of poorer DSS were identified, Cell Cancer Collaborative Group.3 On including the rate of change of HCG multivariate analysis, an elevated serum before surgery, an elevated preoperative AFP level before PC-RPLND and the AFP, a prior attempt at a PC-RPLND, size of the retroperitoneal mass on and the presence of viable germ-cell pathology review were both predictive tumor at the time of surgery. of viable tumor in the surgical speciClearly, patients undergoing a PCmen. Unfortunately, aside from the RPLND, a “desperation PC-RPLND,” patients who achieve a complete or a repeat PC-RPLND constitute a response to chemotherapy, none of the high-risk population in terms of disease aforementioned predictors (alone or in progression and surgical morbidity.26,27 combination) can be used with suffi- Nevertheless, an aggressive and comcient accuracy to avoid surgery in any plete resection may offer a chance at long-term survival and cure in patients other subset of patients. Progression-free survival (PFS) after requiring surgical consolidation followPC-RPLND can be predicted based on a ing chemotherapy, and in patients combination of various clinical and exhibiting chemorefractory behavior.

august 2010 I VOL 3, NO 5

Understandably, this operation should be performed at tertiary care referral centers with extensive experience in the surgical management of complex testis cancer cases. Postoperative follow-up Following PC-RPLND, patients remain at risk of disease recurrence predominantly within the chest (49%), abdomen (22%), and supraclavicular lymph nodes (13%).25 The risk of an infield recurrence remains acceptably low (1%) when surgery is performed at centers of excellence by experienced surgeons. In a recent retrospective review of patients undergoing PC-RPLND at The M. D. Anderson Cancer Center, the risk of disease recurrence was strongly associated with the patient’s clinical stage. Based on the patterns of recurrence following PC-RPLND for metastatic NSGCTs, a stage-specific surveillance guideline was proposed (Table).25 The surveillance strategy was based entirely on the patterns of recurrence over a 25year period, during which systemic chemotherapeutic regimens evolved dramatically. However, using a combination of history, physical examination, serum tumor markers, and radiologic imaging (chest film, abdominal/pelvic CT imaging), the surveillance strategy provides a framework that can be adopted by clinicians to help identify recurrences at their most likely time and site of occurrence. Conclusions Patients with metastatic testicular cancer have a high probability of cure with multimodality therapy, consisting of systemic chemotherapy and PCRPLND. Careful detail to patient- and disease-related parameters may optimize the cancer-specific outcomes while minimizing morbidity. Metastatic NSGCTs serve as a model on how the optimal integration of effective systemic chemotherapy and surgical consolidation (ie, PC-RPLND) can render excellent oncologic outcomes. This requires a commitment by each member of the multidisciplinary team to communicate effectively and acknowledge the individual contributions each can make toward the care and toward the cure of testis cancer patients. Future basic science and clinical studies will help better define ways of optimizing the outcomes in this young patient population. l References 1. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2009. CA Cancer J Clin. 2009;59:225-249. 2. Mannuel HD, Hussain A. Update on testicular germ cell tumors. Curr Opin Oncol. 2009;21:254-259. 3. International Germ Cell Cancer Collaborative Group. International Germ Cell Consensus Classification: a prognostic factor-based staging system for metastatic germ cell cancers. J Clin Oncol. 1997;15:594-603. 4. Srinivas S, Freiha FS. Actinomycin D revisited in testicular cancer: a case report. Tumori. 1999;85:78-79. 5. Bosl GJ, Geller NL, Bajorin D, et al. A randomized trial of etoposide + cisplatin versus vinblastine + bleomycin + cisplatin + cyclophosphamide + dactinomycin in patients with good-prognosis germ

cell tumors. J Clin Oncol. 1988;6:1231-1238. 6. Horwich A, Sleijfer DT, Fossa SD, et al. Randomized trial of bleomycin, etoposide, cisplatin compared with bleomycin, etoposide, and carboplatin in good-prognosis metastatic nonseminomatous germ cell cancer: a Multiinstitutional Medical Research Council/European Organization for Research and Treatment of Cancer Trial. J Clin Oncol. 1997;15:1844-1852. 7. Culine S, Theodore C, Terrier-Lacombe MJ, Droz JP. Are 3 cycles of bleomycin, etoposide, and cisplatin or 4 cycles of etoposide and cisplatin equivalent optimal regimens for patients with good risk metastatic germ cell tumors of the testis? The need for a randomized trial. J Urol. 1997;157:855-858. 8. Culine S, Kramer A, Theodore C, et al. Randomized trial comparing bleomycin/etoposide/cisplatin with alternating cisplatin/cyclophosphamide/ doxorubicin and vinblastine/bleomycin regimens of chemotherapy for patients with intermediate- and poor-risk metastatic nonseminomatous germ cell tumors: Genito-Urinary Group of the French Federation of Cancer Centers Trial T93MP. J Clin Oncol. 2008;26:421-427. 9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Testicular Cancer. V.1.2008. www.nccn.org/professionals/physician_gls/ PDF/testicular.pdf. Accessed August 24, 2009. 10. Farhat F, Culine S, Theodore C, et al. Cisplatin and ifosfamide with either vinblastine or etoposide as salvage therapy for refractory or relapsing germ cell tumor patients: the Institut Gustave Roussy experience. Cancer. 1996;77:1193-1197. 11. Broun ER, Nichols CR, Turns M, et al. Early salvage therapy for germ cell cancer using high-dose chemotherapy with autologous bone marrow support. Cancer. 1994;73:1716-1720. 12. Einhorn LH. Testicular cancer as a model for a curable neoplasm: the Richard and Hinda Rosenthal Foundation Award Lecture. Cancer Res. 1991;41(9 pt 1):3275-3280. 13. Donohue JP, Leviovitch I, Foster RS, et al. Integration of surgery and systemic therapy: results and principles of integration. Semin Urol Oncol. 1989;16:65-71. 14. Logothetis CJ, Samuels ML, Trindade A, Johnson DE. The growing teratoma syndrome. Cancer. 1982;50:1629-1635. 15. Spiess PE, Kassouf W, Brown GA, et al. Growing teratoma syndrome: The M. D. Anderson Cancer Center experience. J Urol. 2007;177:1330-1334. 16. Murphy BR, Breeden ES, Donohue JP, et al. Surgical salvage of chemorefractory germ cell tumors. J Clin Oncol. 1993;11:324-329. 17. Beck SDW, Foster RS. Long-term outcome of retroperitoneal lymph node dissection in the management of testis cancer. World J Urol. 2006;24:267-272. 18. Kakiashvili D, Anson-Cartwright L, Moore M, et al. Post-chemotherapy retroperitoneal lymph node dissection for testicular germ cell tumors: Is surgery indicated in all and is bilateral template necessary? Princess Margaret Hospital experience. J Urol. 2009;181:325. Abstract 911. 19. Sheinfeld J. The role of adjunctive postchemotherapy surgery for nonseminomatous germ-cell tumors: current concepts and controversies. Semin Urol Oncol. 2002;20:262-271. 20. Stephenson AJ, Sheinfeld J. The role of retroperitoneal lymph node dissection in the management of testicular cancer. Urol Oncol. 2004;22:225-235. 21. Spiess PE, Brown G, Liu P, et al. Predictors of outcome in patients undergoing postchemotherapy retroperitoneal lymph node dissection for testicular cancer. Cancer. 2006;107:1483-1490. 22. Spiess PE, Brown G, Pisters LL, et al. Viable malignant germ cell tumor in the postchemotherapy retroperitoneal lymph node dissection specimen: can it be predicted using clinical parameters? Cancer. 2006;107:1503-1510. 23. Fizazi K, Tjulandin S, Salvioni R, et al. Viable malignant cells after primary chemotherapy for disseminated nonseminomatous germ cell tumors: prognostic factors and role of postsurgery chemotherapy—results from an international study group. J Clin Oncol. 2001;19:2647-2657. 24. Spiess PE, Tannir NM, Brown GA, et al. Recurrence in nonseminomatous germ cell testis tumor patients with no viable tumor at time of postchemotherapy retroperitoneal lymph node dissection. Urology. 2007;70:1173-1178. 25. Spiess PE, Brown GA, Liu P, et al. Recurrence patterns and proposed surveillance in patients following post-chemotherapy retroperitoneal lymph node dissection. J Urol. 2007;177:131-138. 26. Beck SD, Foster RS, BihrleR, et al. Pathologic findings and therapeutic outcome of desperation postchemotherapy retroperitoneal lymph node dissection in advanced germ cell cancer. Urol Oncol. 2005;23:423-430. 27. Sexton WJ, Wood CG, Kim R, Pisters LL. Repeat retroperitoneal lymph node dissection for metastatic testis cancer. J Urol. 2003;169:1353-1356.

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These activities are supported by an educational grant from Millennium Pharmaceuticals, Inc.

Psychosocial Issues

A Team Approach to Psychosocial Care By Susan S. Hendrick, PhD Horn Professor of Psychology, Texas Tech University, Lubbock Everardo Cobos, MD Professor and Associate Dean for Oncology Programs; Division Chief, Oncology/Hematology, Texas Tech University, School of Medicine, Lubbock Vasia Craddick, RNC, BSN Director of Clinical Operations, Southwest Cancer Treatment and Research Center, Lubbock, Texas

Case Report Karen is a 35-year-old married mother of two (Anna, age 11 and Kevin, age 9), who is a high school history teacher. She visited her primary care physician after she found a lump in her breast. Subsequent testing confirmed there was a small mass. She was diagnosed with stage II, non–estrogen-dependent cancer in her left breast. Treatment involved lumpec-

tomy, radiation, and chemotherapy—as well as patient education, navigation through the healthcare system, and individual, couple, and family counseling. The individual counseling focused on anxiety, depression, and the pressure to think positive. The couple counseling focused on patient and caregiver stresses, caregiver burden, and communication

Left to right, front row: Kristin Goodheart, Abby Diehl, Erin Logue, Andrew Friedman; back row: Susan Hendrick, Ryan Graham, Matt Ashton, RB Watts, Cynthia Willmon.

The ripple effect This case example presents state-ofthe-art treatment for cancer, and it can take place in virtually every cancer center and oncology practice in the community. Cancer’s ripple effect is apparent to all who work in oncology. The traditional medical focus has been on the patient’s disease, sometimes on the patient and the disease, and in recent years also on those closest to the patient who are most hit by the ripple effect. Many eminent organizations have taken note of this ripple effect and its psychosocial cost for the patient and close others. The Institute of Medicine addressed psychosocial issues in its volume Cancer Care for the Whole Patient: Meeting Psychosocial Needs,1 and other publications such as those from the American Cancer Society address cancer’s emotional toll. This article describes a practical, counseling team approach to psychosocial care that works effectively within the larger multidisciplinary team approach common in many of today’s cancer treatment settings.

august 2010 I VOL 3, NO 5

The cancer center The Southwest Cancer Treatment and Research Center (SCTRC) is a regional cancer center affiliated with Texas Tech University School of Medicine and administered jointly by Texas Tech University Health Sciences Center and University Medical Center (UMC), a teaching hospital that is also the county hospital. SCTRC had more than 24,000 patient visits in 2009. It is accredited by the American College of Surgeons Commission on Cancer and is a member of the Southwest Oncology Group, the Children’s Oncology

between the spouses. Family counseling focused on offering age-appropriate information about both breast cancer and their mother’s condition for the children, describing the family as a team, and providing a picture of the family’s new normal. Karen is now in remission, yet the cancer center counselors continue to check in with her at every visit.

Group, and the Cancer Trials Support Unit. SCTRC is involved in numerous clinical trials. It also administers an inpatient bone marrow transplant (BMT) unit and serves a large catchment area in west Texas and eastern New Mexico. Although it began in 1991 and opened a greatly expanded and updated facility in 2004, the SCTRC did not offer a consistent program of psychosocial services until summer 2004, when it began a novel partnering with Texas Tech University’s Department of Psychology. Aided initially by a federal grant, a practicum site for clinical and counseling psychology doctoral students was set up at SCTRC. Beginning with one student and currently sustaining 8 students, SCTRC has nurtured its counseling team even as it has added other psychosocial providers, such as its patient navigator who is funded, in part, by the American Cancer Society. What the team does The current team of 10 includes three students with positions funded by UMC for 10 hr/week, and seven students working either 0.5 day/week (a half practicum) or two 0.5 day/week (a full practicum). SCTRC is typically staffed for all of the working week (MondayFriday), except Friday afternoons. An additional team member, the supervisor who is a Texas Tech University psychology professor, works 0.5 day/week as the counselor at the dedicated clinic for

Cancer patients and their families have a need to be understood on their very difficult journey and to be appreciated for their struggle. The physician has time pressures, fears not doing enough or doing too much, and has a wish to really connect with each patient and family. Yet no one person can meet all the needs of the patient and his or her family, making the team approach essential. The counselors are observers, translators, and sometimes almost serve as a physician’s sixth sense. The counselors are a natural part of the treatment team. I don’t know how we used to get along without them. —Everardo Cobos, MD, Chief Medical Oncologist

lung cancer patients. This clinic is also staffed by a medical oncologist, pulmonologist, lung surgeon, and nurse practitioner. Students typically self-select into a particular site within SCTRC, though the team members carry pagers and attempt to provide coverage wherever it is needed. Some counselors work alongside physicians and extenders in the outpatient clinics, whereas others prefer the infusion area or the BMT unit, where they can spend more time talking with patients and family members. All counselors try to help staff the radiation area. A patient, such as the one in the case example, might encounter several counselors in the course of his or her treatment, for example, touching base briefly in the clinic, talking at greater length (and depth) in the infusion suite, and sometimes seeing a counselor in the radiation area. Continuity of care is always an issue. Weekly group supervision of the team and extensive note taking and exchange allow the team to function much like a relay team rather than as a series of unconnected individuals. The team has seen many members come and go during the 6 years of its existence (nearly 30 counselors, including current ones). The unifying themes across students and years have been (1) commitment to patient service, (2) particular interest in working with ill people in an outpatient medical setting, and (3) unfailing team cohesiveness. No one has been recruited to the team; virtually every counselor has sought out the team. Much of the therapeutic work is supportive counseling and assessment of anxiety and depression in patients and, just as commonly, in their spouse/partner. During a recent afternoon, one counselor celebrated with a patient who was diagnosed with a benign breast lump instead of breast cancer, helped an adult woman come to terms with her Continued on page 26

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value-focused www.ValueBasedCancer.com www.ValueBasedCancer.com

New NewTools ToolsArriving ArrivingtotoMeasure Measureand and NCCN NCCNRoundtable: Roundtable:Clinical Clinicaland and Manage Economic ManageChemotherapy ChemotherapyCare Care EconomicIssues IssuesImpacting Impacting Business, Cancer Business,clinical clinicalconcerns concernsnow nowconnected connectedinin CancerCare CareDelivery Delivery value-focused value-focusedapproach approach ByBy Daniel Denvir Daniel Denvir

payers

Baltimore, MD—A long-held business Baltimore, MD—A long-held business truism is is that “if“if you can’t measure it, it, truism that you can’t measure you it.”it.” The application youcan’t can’tmanage manage The application ofofthis thisbelief beliefto tothetheoncology oncologysetting setting was demonstrated at a session of the was demonstrated at a session of the Association AssociationofofCommunity CommunityCancer Cancer Cen ters’ 36th Annual National Cen ters’(ACCC) (ACCC) 36th Annual National Meeting. Kimberly Bergstrom, PharmD, Meeting. Kimberly Bergstrom, PharmD, chief clinical officer for McKesson chief clinical officer for McKesson Specialty Care Solutions, told attendees Specialty Care Solutions, told attendees ofof thethe growing importance of of developing growing importance developing and andusing usingstandardized standardizedchemotherapy chemotherapy treatment regimens, and of of thethe tools that treatment regimens, and tools that

cost control

clinical practice guidelines

“Collision “Collisioncourse” course”ininsight sight cancan benchmark performance andand foster benchmark performance foster compliance with treatment guidelines. Dr DrGoodman Audrey Andrews Goodman compliance with treatment guidelines. By By Audrey Andrews Public and private payers areare movalluded to atolevel Public and private payers movalluded a level ingingto tocontrol exploding healthcare thatthat of frustration control exploding healthcare Hollywood, Hollywood,FL—Clinical FL—Clinicalpractice practice of frustration never been costs, told attendees, issued by by thethe National costs,DrDrBergstrom Bergstrom told attendees, guidelines guidelines issued National hashas never been and control in in cancer andbecause becauseincreased increasedcost cost control Comprehensive ComprehensiveCancer CancerNetwork Network higher higher cancer was areare followed by by conscien“Too many wasinevitable, inevitable,it itis isin inproviders’ providers’ (NCCN) (NCCN) followed conscien- care. care. “Too many interest to to getget a seat at at thethe table. tious oncologists in in their everyday areare stillstill interest a seat table. tious oncologists their everyday patients patients “It“It is is anan important topic, because areare developed young. WeWe important topic, because practice, practice,butbutthey they developed dying dying young. this is one of of those things, if we don’t on on clinical efficacy andand without innovations andand a cure,” he said. this is one those things, if we don’t based based clinical efficacy without need need innovations a cure,” he said. getget a handle on it, it’s going to happen regard to costs. At a roundtable held But the inadequacy of current treatof current treata handle on it, it’s going to happen regard to costs. At a roundtable held But the inadequacy to to us,” sheshe said. “People and groups NCCN’s 15th Annual for for cancer is no the the main us,” said. “People and groups during duringthethe NCCN’s 15th Annual ments ments cancer is longer no longer main Equally challenging, he sugand organizations areare going to to start and organizations going start Conference, Conference, moderator moderator Clifford Clifford problem. problem. Equally challenging, he sugdictating how we provide cancer care, Goodman, PhD, Senior Vice President gested, is finding a means to pay for dictating how we provide cancer care, Goodman, PhD, Senior Vice President gested, is finding a means to pay for and wewe can’t letlet that happen.” at The Lewin Group, predicted, “The ever-costlier carecare thatthat threatens to to and can’t that happen.” at The Lewin Group, predicted, “The thethe ever-costlier threatens appropriate use of evidence-based bankrupt the healthcare system. Continued on page 8 appropriate use of evidence-based bankrupt the healthcare system. Continued on page 8 guidelines is on a collision course As society struggles to find soluAs society struggles to find soluguidelines is on a collision course with the financial nonsustainability of tions, “the ground is shaking beneath with the financial nonsustainability of tions, “the ground is shaking beneath the healthcare system.” us,” Dr Goodman commented. the healthcare system.” us,” Dr Goodman commented.

Value-Based Value-BasedCancer CancerCare Care will willbebeatatthe theASCO ASCOAnnual Annual Meeting, June 4-8, in Chicago. Meeting, June 4-8, in Chicago.

Continued on page 19 Continued on page 19

Please visit usus atat booth 18121 Please visit booth 18121

SEER-Medicare SEER-MedicareDatabase DatabaseAnalysis Analysis Confirms Expensive Prostate Confirms Expensive Prostate Breast BreastCancer CancerSurvival SurvivalImproves, Improves, Cancers CancersGaining GainingSupremacy Supremacy Photo by © ASCO/Todd Buchanan 2009 Photo by © ASCO/Todd Buchanan 2009

Thanks ThankstotoNew NewTherapies Therapies

efficacy

cost effectiveness

But remains to to Butcost-effectiveness cost-effectivenessofofthis thismove move remains bebedetermined determined

Breast Cancer Conference (EBCC7). Breast Cancer Conference (EBCC7). This improvement, the researchers By Rosemary Frei, MSc This improvement, the researchers By Rosemary Frei, MSc Barcelona—Survival for patients with suggest, is due to increased use of The 2010 Genitourinary Cancers Barcelona—Survival for patients with suggest, is due to rise increased use of San Francisco, CA—The popularity of The 2010 Progress Genitourinary Cancers metastatic breast cancer has improved anthracyclines and the of targeted Symposium: in Multi San Francisco, CA—The metastatic breast has improved anthracyclines and the rise of targeted minimally Symposium: Progresswas in held Multidramatically in the cancer last 20 years, espe- therapies. Management invasive radical popularity prostatec- of disciplinary minimally radical prostatec- March dramatically in the last 20 years,with espe- “There therapies. disciplinary Management cially in the subgroup of patients is no doubt that trastuzu- tomy 5-7 in San Francisco. Allwas ses-held (MIRP),invasive intensity-modulated tomy (MIRP), intensity-modulated cially in the subgroup of patients with “There is no doubt that trastuzu March 5-7 in San Francisco. All HER2-positive tumors, according to mab (Herceptin), which targets the radiation therapy (IMRT), and of sions emphasized a multidisciplinarysesradiation therapy (IMRT), and of approach HER2-positive mab gene, (Herceptin), which important targets the brachytherapy sions emphasized a multidisciplinary research presentedtumors, at the 7thaccording European to HER2 is the most to care; a number of them combined with IMRT research presented at the 7th European HER2 gene, is the most important forbrachytherapy approach to cost care;and a number of them brought out the value issues prostate cancercombined started towith take IMRT off Continued on page 27 for 2002, prostate cancer started analysis to take off associated broughtwith out the cost for andgenitourivalue issues Continued on page 27 after caring a new database after 2002, a new database analysis associated with caring for genitourinary cancers. has confirmed. hasthe confirmed. nary cancers. At American Society of Clinical At the American Society of Can Clinical Oncology’s 2010 Genitourinary - and Women’s Hospital, Harvard Oncology’s 2010Paul Genitourinary Can- Medical and Women’s Hospital, Harvard School, Boston, and his cocers Symposium, L. Nguyen, cerspresented Symposium, Nguyen, Medical School, his coMD, the Paul resultsL. of his investigators foundBoston, MIRP and jumped investigators found MIRP jumped MD, analysis presentedof the team’s dataresults from of thehis from 1.5% of radical prostatectomies team’s analysis of dataand from from of 28.7% radicalinprostatectomies Surveillance, Epidemiology Endthe (RPs) in 1.5% 2002 to 2005. They Surveillance, Epidemiology and End also(RPs) in 2002 28.7% in 2005. They Results (SEER)-Medicare database. found that to IMRT soared from also found that IMRT treatments soared from Results (SEER)-Medicare Dr Nguyen, director of database. Prostate 8.7% of external radiation Dr Nguyen, director of Prostate for 8.7% of external radiation treatments prostate cancer to 81.7%. In addiBrachytherapy, Dana-Farber/Brigham Brachytherapy, Dana-Farber/Brigham for prostate cancer to 81.7%. In 24 addiContinued on page

By Colin Gittens By Colin Gittens

targeted therapies

Continued on page 24

A new publication for your new vocabulary

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Benchmarking

Benchmarking Performance in a Physicianowned Practice By Teri U. Guidi, MBA, FAAMA President & CEO, Oncology Management Consulting Group and The Oncology Business Institute, Pipersville, Pennsylvania

ith costs rising and what audience combiand reimbursenation will allow identificaments failing to tion of actionable opportukeep pace, physician pracnities for improvement. tices need to ensure optiClearly, you want to be mal performance and effiable to compare your own ciency. Benchmarking is practice with others to find intended to compare your the places where you are less practice with regional or successful. There are several national standards and/or challenges with using exterwith itself, and to evaluate Teri U. Guidi, MBA, FAAMA nal benchmarks. As menyour performance over tioned, benchmark data are time using objective and measurable often available only on an annual basis. data elements. The point is to improve In addition, it can be very difficult to productivity and performance: costs, ensure that the external source’s definirevenue, throughput, etc. In general, tion of the metric is the same as your the results are expressed in work prod- own. For example, if the metric refers to uct generated per a related resource. For FTE physician, you need to be sure that example: your definition is comparable—hours • New patients per full-time equiva- spent in clinical activities perhaps, or lent (FTE) physician total number of new patients seen per • Total FTE staff per FTE physician year or work relative value units, comor chemotherapy nurse monly referred to as RVUs. • Total revenue per year or per new Sources for external benchmark data patient vary widely. Informal benchmarking • Medical revenue per FTE billing comes from conversations at meetings, staff. visits with colleagues, or participation To get started, you first need to deter- in listserves. More formal sources mine what you will measure and com- include use of published data in the propare. These should be measures that fessional literature, purchased data sets, hold the promise of contributing to the professional society surveys, memberpractice’s real performance. Choose ship in a collaborative, or subscription things that are within your power to memberships. Without spending addichange and improve to the benefit of tional money, you are generally dependthe practice. Don’t measure something ent on networking with colleagues or just because it is measurable or because on published articles summarizing suryou are just curious. There is little point veys for use as external benchmarks. in expending the time and energy to Unfortunately, these rarely repeat benchmark if you are not committed to themselves one year to the next, limit(or able to) then act on the results. ing your ability to use them over time. Next, decide how frequently you will Membership in professional associameasure and compare. In most cases, tions can provide some benchmarks as external benchmark data are only avail- well as networking opportunities at a able and updated annually. Also for cost that is already being paid for those many benchmarks, annual or semian- memberships. For oncology, the potennual review is sufficient, because effect- tial sources of benchmarking data ing changes in performance takes time include: to accomplish and then time to meaPurchased data sets: sure. Although the examples in this • Medical Group Management Assoarticle refer to medical oncology pracciation’s (MGMA) cost survey tices, the concepts can be applied to vir• MGMA’s physician compensation tually any physician office practice. and productivity survey. After you have decided what you will Membership surveys: measure and how frequently, determine • State oncology society how you will present the findings and to • MGMA’s assembly of oncology whom. For example: Will you develop hematology administrators narrative reports or graphic depictions? • Association of Community Can(See Figures 1 and 2.) Will these be cer Centers. delivered without personal interaction Collaboratives/subscriptions: periodically or will they be reviewed at a • Oncology Circle (physician pracmonthly meeting of staff with the opportices) tunity for discussion? As when choosing • The Oncology Business Institute what to measure, consider what format (hospital outpatient services).

august 2010 I VOL 3, NO 5

Track and Trend Revenue & Drug Spending

Revenue/FTE Biller Drug spend/FTE Physician Revenue: benchmark Drug spend: benchmark

Figure 1. Sample Chart of Tracking and Trending of Revenue per FTE Biller and Drug Expenditures per FTE Physician Data are fictitious and are for the purpose of illustration only. FTE indicates full-time equivalent.

Track and Trend New Patients & Infusion

New patients/FTE Physician Infusion encounters/FTE Chemotherapy Nurse New patients: benchmark Infusion encounters: benchmark

Figure 2. Sample Chart of Tracking and Trending of New Patients per FTE Physician and Infusion Encounters per FTE Chemotherapy Nurse Data are fictitious and are for the purpose of illustration only. FTE indicates full-time equivalent.

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Benchmarking Publications: • Hematology & Oncology News & Issues • Journal of Oncology Practice • Oncology Business Review • Oncology Issues. Equally important to external comparison, however, is measuring your own performance over time—especially if you already “beat” the benchmark. The goal is continuous improvement, not just being assured that you are doing as well as everyone else. You are looking for a consistent trend in a positive direction. After your first round of measuring, examine each point that you have included. Does your performance leave room for useful change? If not, decide whether repeating this metric is worthwhile or if another should be substituted. If useful change is possible, bring together the needed individuals to ensure that all understand the metric and then to develop and implement an action plan and accompanying targets for future performance. For example, if you have chosen as a metric “pharmacy dollars spent per FTE physician,” and if your performance is worse than desired (perhaps anything below mean or median in the benchmark data), your team would include one or more physicians, the individual responsible for drug-purchasing decisions (quantities, vial sizes, schedule, days inventory turn, etc), and individual(s) responsible for choosing vials and mixing/wasting drug. This team may need to do some research to fully understand the impact of their relationships to the outcomes. Then, the team can brainstorm ways to reduce the total oncology spend as well as the cost and quantity of drugs on hand (tying up cash and frequently resulting in unintended waste). As another example, perhaps you have chosen “medical revenue per FTE biller.” This multifaceted issue has many contributing factors. Are your chargecapture processes missing any billable items? Does your charge-entry system interface correctly with the billing system or are items inadvertently omitted? Does the billing system receive all the required information to produce a clean claim? Are you collecting according to contract or are items going unpaid unnecessarily? Does your billing and collections staff spend unnecessary time resubmitting and appealing? Are your contracts as favorable as possible? Only after answering these questions can you focus on the possibility that you simply have too many staff members in the billing department. By now it should be obvious that you will need a system for regularly calculating your performance. At its simplest, this might be a person who understands your practice management and elec-

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tronic health record systems and who can set up relatively simple spreadsheets or other tools to track and report results. Your own internal sources of data will vary, but likely will include: • Procedure productivity report from your practice management system. This can be used for almost all pro-

ductivity measures, because it will include volume of Current Procedural Terminology (CPT) codes, units of service, and collected revenue. • Additional financial reports provide data on income, staffing costs, operating expense, drug costs, etc. • Human resource records add to the

mix the information on FTEs in various roles. In the final analysis, the two most important things are to systematically and regularly track your own performance over the course of time and to act on the results, formulating and implementing plans for improvement. l

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Making Access easier.

august 2010 I VOL 3, NO 5

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

Medications Used for the Treatment of Colorectal Cancer Colon cancer forms in the tissues of the colon (the longest part of the large intestine). Most colon cancers are adenocarcinomas (cancers that begin in cells that make and release mucus and other fluids). Rectal cancer forms in the tissues of the rectum (the last several inches of the large intestine closest to the anus). The following sections will assist healthcare professionals and payers by providing appropriate coding, billing, and reimbursement information associated with the management of colorectal cancer. The following sections include: • Associated ICD-9-CM codes used for the classification of colorectal cancer • Drugs that have been FDA-approved in the treatment of colorectal cancer • Drugs that are Compendia listed for off-label use for colorectal cancer based on clinical studies that suggest beneficial use in some cases. Please note: if a check mark appears in the FDA column it will NOT appear in the compendia off-label use column • Corresponding HCPCS/CPT® codes and code descriptions • Current Code Price (AWP-based pricing) • Most recent ASP plus 6% (Medicare allowable), if applicable • Possible CPT® Administration Codes for each medication

generic (Brand) name

HCPCS code: code description

bacillus Calmette-Guerin (Tice BCG, TheraCys) bevacizumab (Avastin) capecitabine (Xeloda) capecitabine (Xeloda) carmustine (BiCNU) cetuximab (Erbitux) cisplatin (Platinol AQ) cisplatin (Platinol AQ)

J9031: bCG (intravesical), per installation J9035: injection, bevacizumab, 10 mg J8520: capecitabine, oral, 150 mg J8521: capecitabine, oral, 500 mg J9050: injection, carmustine, 100 mg J9055: injection, cetuximab, 10 mg J9060: cisplatin, powder or solution, per 10 mg J9062: cisplatin, 50 mg

august 2010 I VOL 3, NO 5

Associated ICD-9-CM Codes Used for Colorectal Cancer 153 Malignant neoplasm of colon Excludes: benign carcinoid tumor of colon (209.50-209.56) malignant carcinoid tumor of colon (209.10-209.16) 153.0 Hepatic flexure 153.1 Transverse colon 153.2 Descending colon Left colon 153.3 Sigmoid colon Sigmoid (flexure) Excludes: rectosigmoid function (154.0) 153.4 Cecum Ileocecal valve 153.5 Appendix 153.6 Ascending colon Right colon 153.7 Splenic flexure 153.8 Other specified sites of large intestine Malignant neoplasm of contiguous or overlapping sites of colon whose point of origin cannot be determined Excludes: ileocecal valve (153.4) rectosigmoid junction (154.0) 153.9 Colon, unspecified Large intestine, not otherwise specified 154 Malignant neoplasm of rectum, rectosigmoid junction, and anus Excludes: benign carcinoid tumor of rectum (209.57) malignant carcinoid tumor of rectum (209.17) 154.0 Rectosigmoid junction Colon with rectum Rectosigmoid (colon) 154.1 Rectum Rectal ampulla 154.8 Other Anorectum Cloacogenic zone Malignant neoplasm of contiguous or overlapping sites of rectum, rectosigmoid junction, and anus whose point of origin cannot be determined

FDAapproved for colorectal cancer

Compendia listed off-label use for colorectal cancera

Current code price (AWP-based pricing), effective 7/1/10

Medicare allowable (ASP + 6%), effective 7/1/10-9/30/10

CPT ® administration codes

$169.10

$110.31

96413, 96415

✓

$66.99

$58.45

96413, 96415

✓

$8.52

$6.86

96413, 96415

✓

$28.41

$22.48

96413, 96415

$205.69

$176.15

96413, 96415

$57.60

$49.73

96413, 96415

✓

$4.33

$1.89

96409, 96413, 96415

✓

$21.66

$9.45

96409, 96413, 96415

✓

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ONCOLOGY DRUG CODES Supplied by: RJ Health Systems

generic (Brand) name

HCPCS code: code description

doxorubicin (Adriamycin) floxuridine (FUDR) fluorouracil (Adrucil) irinotecan (Camptosar) leucovorin calcium (Wellcovorin)

J9000: injection, doxorubicin hydrochloride, 10 mg J9200: injection, floxuridine, 500 mg J9190: injection fluorouracil, 500 mg J9206: injection, irinotecan, 20 mg J0640: injection, leucovorin calcium, per 50 mg J0641: injection, levoleucovorin calcium, 0.5 mg

levoleucovorin calcium (Fusilev) lomustine (CeeNu) lomustine (CeeNu) methotrexate sodium methotrexate sodium mitomycin (Mutamycin) mitomycin (Mutamycin) mitomycin (Mutamycin) mitoxantrone (Novantrone) oxaliplatin (Eloxatin) panitumumab (Vectibix) pemetrexed (Alimta) teniposide (Vumon) topotecan (Hycamtin) topotecan (Hycamtin) vinCRIStine (Vincasar) vinCRIStine (Vincasar) vinCRIStine (Vincasar)

FDAapproved for colorectal cancer

Compendia listed off-label use for colorectal cancera

Current code price (AWP-based pricing), effective 7/1/10

Medicare allowable (ASP + 6%), effective 7/1/10-9/30/10

CPT ® administration codes

✓

$13.20

$2.94

96409

✓

$121.06

$43.10

✓

$3.37

$1.48

96409

✓

$31.48

$6.79

96413, 96415

✓

$3.60

$0.95

96372, 96374, 96409

✓

$1.54

$0.65

96365, 96366

J8999b: prescription drug, oral, chemotherapeutic, not otherwise specified S0178: lomustine, oral, 10 mg

✓

NDC level pricing $10.59

J9250: methotrexate sodium, 5 mg J9260: methotrexate sodium, 50 mg J9280: mitomycin, 5 mg

✓

$0.29

NDC level pricing S0178: not payable by Medicare $0.19

✓

$2.86

$1.92

✓

$67.20

$20.19

96372, 96374, 96401, 96409, 96450 96372, 96374, 96401, 96409, 96450 96409

J9290: mitomycin, 20mg

✓

$218.40

$80.74

96409

J9291: mitomycin, 40 mg

✓

$300.00

$161.48

96409

J9293: injection, mitoxantrone hydrochloride, per 5 mg J9263: injection, oxaliplatin, 0.5 mg J9303: injection, panitumumab, 10 mg J9305: injection, pemetrexed, 10 mg Q2017: injection, teniposide, 50 mg J8705: topotecan, oral, 0.25 mg J9350: injection topotecan, 4 mg J9370: vincristine sulfate, 1 mg J9375: vincristine sulfate, 2 mg J9380: vincristine sulfate, 5 mg

✓

$106.50

$40.88

96409, 96413

✓

$8.25

$4.46

96413, 96415

✓

$101.85

$87.24

96413, 96415

✓

$60.67

$51.69

96409

✓

$376.55

$324.27

✓

$89.73

$74.59

✓

$1,306.10

$1,058.74

96413

✓

$7.22

$4.53

96409

✓

$14.44

$9.06

96409

✓

$36.10

$22.65

96409

96422, 96423, 96425

N/A

96413, 96415 N/A

Continued on page 26

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august 2010 I VOL 3, NO 5

ONCOLOGY DRUG CODES Supplied by: RJ Health Systems Continued from page 25

Compendia references available upon request. When billing a non-classified medication using a CMS 1500 claim form you must include both the HCPCS code (ie, J8999 for CeeNu) in Column 24D and the drug name, strength, and National Drug Code (NDC) in Box 19 in order to ensure appropriate reimbursement. a

References HCPCS Level II Expert 2010 • Current Procedural Terminology (CPT®) 2010 • ICD-9-CM for Professionals Volumes 1 & 2 2010 • The Drug Reimbursement Coding and Pricing Guide by RJ Health Systems International, LLC, Volume 7, Number 3, 3rd Quarter 2010 • FDA-approved indication (from product’s prescribing information) • National Cancer Institute® • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Wethersfield, Connecticut • CMS (Centers for Medicare & Medicaid Services)—Medicare Allowable 3rd Quarter 2010 (effective dates 7/1/109/30/10). Prices listed herein are effective as of July 1, 2010. ASP indicates average sales price; AWP, average wholesale price; CMS, Centers for Medicare & Medicaid Services; CPT®, Current Procedural Terminology; FDA, US Food and Drug Administration; HCPCS, Healthcare Common Procedure Coding System; NDC, National Drug Code.

This information was supplied by:

PO BOX 290616, Wethersfield, CT 06109 T: (860) 563-1223 • F: (860) 563-1650 www.RJHealthSystems.com

PSYCHOSOCIAL ISSUES

A Team Approach...continued from page 20 father’s cancer diagnosis, emphasized the value of hospice services for an older widow recently referred to hospice, established rapport with a new patient and her husband by commenting on how the husband’s nonverbal behaviors answered the physician’s question even before the patient answered them (a humorous bonding moment for counselor and couple), and stood next to a favorite longtime patient when he was told that his cancer had recurred. Many counselors have referred to their work

Nurses receive both medical and interpersonal skills training. I have come to view most patients who have a cancer diagnosis as remarkable. They endure difficult treatment and sometimes worry more about others, like spouses, than they do about themselves. Sometimes a spouse is more stressed about the patient’s condition; sometimes a spouse is less accepting of the reality of how the patient is doing. I believe that nurses do a good job medically and interpersonally in spite of limited time and resources, but patients and their families are often in deep emotional distress. The counselors help patients and families directly. In addition, partnering with the counselors helps me help each patient more effectively. We really are a team. —Vassia Craddick, RCN, BSN Nurse Director of Clinical Services

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at SCTRC as a “gift,” and counselor satisfaction with their SCTRC experience is high. How to develop a team Our model of a counseling team is novel, practical, and could serve as a prototype for other cancer centers and community oncology practices.2 Oncology practices could partner with a local college or university, most of which would have undergraduate/graduate programs in psychology, counseling, or social work. Students in such programs are commonly required to participate in practica or externships in a community agency or other setting. A cancer center is a perfect setting, given the right preparation for both students and practicum site. Often a practicum site will provide supervision for the practicum students. If that is not available, by providing really good training for students, a site would likely obtain supervision from the academic unit whose students it trains. The process of arranging such a partnership is not difficult. It simply requires due diligence, excellent communication, mutual respect, and the shared goal of providing training opportunities for psychosocial professionals and improving psychosocial cancer care for patients and their families and caregivers. The goals are worthwhile and achievable. l References 1. Institute of Medicine Committee on Psychosocial Services to Cancer Patients/Families in a Community Setting; Adler NE, Page AEK, eds. Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs. Washington, DC: The National Academies Press; 2008.

Recent FDA Approvals Cabazitaxel for Metastatic Prostate Cancer The US Food and Drug Administration (FDA) has approved cabazitaxel (Jevtana injection, sanofi-aventis) for use in combination with prednisone for treatment of metastatic hormone-refractory prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. Approval was based on results from a randomized, open-label, international trial of 775 men with mHRPC previously treated with docetaxel-containing regimens who received intravenous cabazitaxel in combination with prednisone or intravenous mitoxantrone in combination with prednisone. The median overall survival for patients receiving the cabazitaxel regimen was 15.1 months compared with 12.7 months for those who received the mitoxantrone regimen. Cabazitaxel was reviewed under the FDA’s priority review program. Ondansetron Oral Soluble Film for Cancer-related Nausea and Vomiting The FDA has approved ondansetron (Zuplenz, Strativa) oral soluble film for the prevention of postoperative, highly and moderately emetogenic chemotherapy-induced and radiotherapy-induced nausea and vomiting. Approval was granted based on study results that showed the bioequivalence of ondansetron 8 mg oral soluble film to 8 mg orally dissolving tablet. The formulation, the first oral soluble

film approved by the FDA as a prescription medicine, can be taken with or without water and under fed or fasting conditions. This formulation meets the needs of patients in which water causes discomfort. Nilotinib for Newly Diagnosed Chronic Myeloid Leukemia The FDA has approved nilotinib (Tasigna, Novartis) for the treatment of adult patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP-CML). The recommended nilotinib dose for this indication is 300 mg orally twice daily. Tasigna has been approved since 2007 for the treatment of adult patients with CP-CML in accelerated phase (APCML) resistant or intolerant to prior therapy that included imatinib. Approval was based on data from the ENESTnd, a phase 3, open-label, multicenter trial. Major molecular response at 12 months was achieved in 22% (95% CI, 18-28) of patients in the imatinib arm, 44% (95% CI, 3850) in the nilotinib 300-mg twice-daily arm, and 43% (95% CI, 37-49) in the nilotinib 400-mg twice-daily arm. Complete cytogenetic response rates by 12 months were 65% (95% CI, 5971) for the imatinib arm, 80% (95% CI, 75-85) for the nilotinib 300-mg twice-daily arm, and 78% (95% CI, 73-83) for the nilotinib 400-mg twicedaily arm. This indication was reviewed under the FDA’s priority review program. l

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Cancer Center Profile Albert Einstein Cancer Center...continued from cover ic groups, some of whom are uninsured or underinsured. But the staff believes they can do better. For example, radiation oncology “has advanced radiation treatment equipment for patient care,” Lawrence J. Solin, MD, FACR, FASTRO, chair, Department of Radiation Oncology, told the Journal of Multidisciplinary Cancer Care. “It is extremely important to make sure that our patients not only have access to treatment, but that we provide them with the support services to complete their prescribed therapy.” To help patients do that, Einstein plans to expand its nutrition, dietary, and social services for patients undergoing radiation oncology. These expansions will go well beyond radiation oncology. “For those patients that are starting chemotherapy for the first time, we have developed what we call a patient teaching appointment. The patient comes in and has one-onone time with a social worker, a treatment nurse, and a dietitian,” said Tiffany Raroha, MSW, one of two oncology social workers at Einstein. The center’s plan is to reach every patient starting a new cancer treatment, expanding social services not only to radiation oncology patients but also to surgical oncology patients. “We plan to be more proactive with doing psychosocial assessments up front with newly diagnosed patients as well as being able to do continuous follow-up of their psychosocial needs,” said Raroha. Einstein also plans to add patient navigators to help patients get through the system more easily. Enhancing quality For more than 20 years, Einstein has employed site-specific multidisciplinary cancer programs. For most disease sites, physicians and support staff meet and discuss all new cases as well as cases where a problem has arisen or a patient

has a recurrence. These groups include more than just the medical, surgical, and radiation oncologists. In addition to these oncologists, for example, the lung cancer program has regular attendance by its thoracic surgeon, its pulmonologist, a research nurse, social services, and a pathologist, according to Tester. In the breast health program, 15 to 20 people meet every Wednesday, including representatives from breast surgery, medical oncology, radiation oncology, radiology, pathology, plastic surgery, genetics, and rehabilitation. “This is a great way to involve all the experts, so when a patient returns for her 1-week checkup after completing her surgery, and I tell her that she needs to see the medical oncologist, that physician has already

“Multidisciplinary care is an initiative that is important to the NCCCP, and we are planning and want to make that work. At the very least, we want to have a multidisciplinary clinic that meets after the tumor board meeting where the patient could actually meet three or four of the clinicians involved in his or her care.” ——William J. Tester, MD, FACP fully reviewed her case. I can tell the patient what the medical oncologist plans on giving her and which trials will be available to her,” said Lisa Jablon, MD, FACS, a breast surgeon who is director of the Breast Health Program. At present, Einstein has multidisciplinary programs in breast cancer, lung cancer, gastrointestinal cancer, and hematologic malignancies, and hopes to develop an active urologic program with the NCCCP funding. To integrate care further, Tester has

Dr William Tester, a medical oncologist, and Tiffany Raroha, an oncology social worker, counsel a patient.

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one initiative he is excited about the possibility of implementing now that Einstein is an NCCCP cancer center. “What we could do with NCCCP support is bring the patient into the multidisciplinary conferences. We have always discussed cases, reviewed pathology, radiologic imaging, and clinical trials that would be appropriate, but we have never actually brought the patient into the discussion room. Multidisciplinary care is an initiative that is important to the NCCCP, and we are planning and want to make that work. At the very least, we want to have a multidisciplinary clinic that meets after the tumor board meeting where the patient could actually meet three or four of the clinicians involved in his or her

care. The presence of the patient will show him or her that our approach is truly multidisciplinary, and that his or her personal issues and input are considered in making final treatment decisions.” In addition, Einstein plans to incorporate more survivorship services. “Our plan is to offer survivorship strategies to all patients at the time of diagnosis and continue that through and beyond treatment,” said Tester. The NCCCP grant allows Einstein to hire a coordinator to run survivorship services. Jablon provided an illustration of how this would work in breast health: “We do have an active cancer program and social workers. Plus, different organizations like the American Cancer Society offer a lot of programs that are integrated with our local hospital, such as Reach to Recovery and Look Good…Feel Better. We would like to make survivorship even more of a focus for our patients after they have passed through their primary treatment. For example, I just got back from a conference where they talked a lot about how we don’t integrate improvements in exercise or weight control into our cancer population. Even though we tell our patients that they need to lose weight, we offer no specific, active programs for them to go out and do that. One of my thoughts

is to go out into the community and organize walking groups of cancer survivors and people interested in cancer prevention to integrate exercise into the community practice.” Clinical trials and biospecimen research Einstein has been active in clinical trials since it was originally funded by the NCI in 1972. “We have always had a strong commitment to offering patients state-of-the-art clinical trials, and I think that is exemplified by the array of clinical trials we offer through the Eastern Cooperative Oncology Group (ECOG), the Radiation Therapy Oncology Group (RTOG), and the National Surgical Adjuvant Breast and Bowel Project (NSABP),” Solin said. “One of the things we would like to do is enhance access to clinical trials for our population through the NCCCP grant.” Biospecimen collection, however, will be something new. “We have done a lot of clinical work at Einstein but not as much in the basic science arena,” said Tester. “But with the NCCCP to support our collection of biospecimens, we are going to be creating our own tissue bank, and we are going to be able to be involved in more translational research activities.” For example, Einstein currently works in collaboration with Thomas Jefferson University, which has a strong basic science program and translational research. Tester believes that Einstein’s involvement in those types of research “could increase as we put aside tumor specimens and ship them for special molecular studies, and then tie that into clinical trials where we are going to evaluate the effect of certain new targeted therapies on patients according to which molecules are expressed by their tumors. With the assistance of Corrado Minimo, MD, and our pathology department, we plan to develop a strong biomarker program.” To the future “Cancer affects not just the patient but the entire family as a unit. So our hope is to expand our program to meet the needs of not just the patient but the family unit. We are hoping we can provide a bereavement program for families of those unfortunate patients who lose the battle to cancer and, possibly, some programs that will meet the needs of children whose parents have cancer,” Raroha said. l

Albert Einstein Medical Center 5501 Old York Road Philadelphia, PA 19141 Einstein Center One 9880 Bustleton Avenue Philadelphia, PA 19115

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The Essential Role of Immunotherapy in Follicular Lymphoma Management LOG ON TODAY TO PARTICIPATE www.coexm.com/ace03.asp Release Date: March 19, 2010 Expiration Date: March 18, 2011

TARGET AUDIENCE This activity is intended for hematologists, oncologists and other healthcare professionals who are involved with the care of patients with follicular lymphoma.

STATEMENT OF NEED Non-Hodgkin's lymphoma (NHL), the most common hematologic malignancy, represents a large proportion of the case load for the typical oncology practitioner. That load is likely to grow, since NHL is increasing in prevalence. The introduction of rituximab, the monoclonal antibody against CD20, changed the treatment landscape of lymphoma and it has been advanced further by immunotherapies that combine CD20-directed targeting with radiotherapy. The recent rapid advances in therapeutics and impressive research across this broad, heterogeneous group of malignancies represent an educational challenge for the clinician trying to stay current and provide the most appropriate, up-to-date therapy tailored for the individual patient. Immunotherapy plays a key role at all stages of the disease in reaching the goal of the highest quality response.

EDUCATIONAL OBJECTIVES On completion of this activity, participants should be able to: • Define the goals of therapy for follicular lymphoma (FL) • Describe strategies for patient selection for immunotherapy (including radioimmunotherapy [RIT]), in both the up-front and relapsed/refractory setting • Define different immunotherapy approaches in terms of efficacy, safety, and tolerability • Propose strategies to overcome adverse events and access issues that create barriers to the provision of optimal immunotherapy in FL

FACULTY Stephanie A. Gregory, MD Professor of Medicine Director, Section of Hematology Rush University Medical Center Chicago, Illinois

David Maloney, MD, PhD Associate Professor of Medicine Division of Oncology University of Washington Member Fred Hutchinson Cancer Research Center Seattle, Washington

With commentary by: Peter S. Conti, MD, PhD Professor Nuclear Medicine Keck School of Medicine University of Southern California Los Angeles, California

This activity is supported by an educational grant from Spectrum Pharmaceuticals.

This activity has been approved for 1.0 AMA PRA Category 1 Credits™. For further information and to participate, please go to: www.coexm.com/ace03.asp

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